The Psychedelic News Feed Archive
March 4th, 2024 - September 1st, 2024
This is an archived version of our Psychedelic News Feed. Receive a weekly digest to your inbox by joining our newsletter. ∎
August 26 - September 1, 2024
This Week’s Feed, Sponsored by…
September 24-26, 2024, Boston, MA
Just four weeks remain until the 7th Neuropsychiatric Drug Development Summit addresses industry’s most pressing scientific, operational, and regulatory challenges for the development of transformative neuropsychiatric candidates. Amidst the recent stall in MDMA progress, the meeting’s timely return will unite leaders from Lykos, Compass, Otsuka, MindMed, Cybin, Gilgamesh and more to share lessons learned, assess progress, and confront the inevitable challenges faced by a new era of psychedelic drug development.
Pα+ Psychedelic Bulletin #171 (Aug 30) ↗ Psychedelic Alpha
- Lykos CEO Provides AdComm Feedback to FDA Commissioner
- Cybin Plans to Fight Functional Unblinding with ‘Firewall’
- Doblin Charts a Future for MAPS • DEA Plots Ketamine Crackdown
- Colorado Closes First Round of Rulemaking for State Psychedelics Program.
- Other Stories, including: MindMed’s Phase 3 program; upcoming FDA-affiliated event on PTSD treatments.
FDA’s MDMA rejection delays PTSD treatment options (Aug 26) ↗ The Hill
After an FDA rejection, here’s what’s next in the psychedelics pipeline (Aug 28) ↗ PharmaVoice
The Magic and Mystery of Psychedelic Therapies (Aug 26) ↗ Columbia Magazine
After Recent MDMA Rejection, Lykos Criticizes FDA Ad Comm Conduct (Aug 29) ↗ Inside Health Policy
What Does FDA Expect from Lykos’ Next Phase 3 MDMA Study? (Part 2) (Aug 28) ↗ Psychedelic Alpha
Despite FDA setback, psychedelic pioneer is unfazed about MDMA’s prospects (Aug 27) ↗ WaPo
I did MDMA therapy before it was legal. For me it was transformative – but I have some concerns (Aug 28) ↗ The Guardian
Mike Tyson stirred talk of psychedelic drugs in sports. Meet other athletes who use. (Aug 29) ↗ USA Today
CEOs are shelling out up to $15,000 for psychedelic mushroom retreats to reinvent their leadership style (Aug 26) ↗ Fortune
Could MDMA save your marriage? (Aug 30) ↗ Women’s Health
How MDMA Highs Can Declutter Your Hoarded Brain—and Help Cure PTSD (Sep 1) ↗ Daily Beast
Vancouver mushroom dispensary back open after winning court ruling (Aug 28) ↗ Global News
I’ve Been Sober for a Year. OK, Except for One Thing. It Still Counts, Right? (Aug 26) ↗ Slate
What’s next for Lykos and psychedelics following FDA rejection? (Aug 28) ↗ Healthcare Brew
The psychedelic revolution — how MDMA mended Rebecca’s mind (aug 30) ↗ ABC (Audio)
Psychedelic Intersections 2025 Call for Papers ↗ Harvard Divinity School
NIH funds study on psychedelics’ potential to treat methamphetamine addiction (Aug 27) ↗ News Medical
Taxpayers lose £460,000 investment in former Tory MP’s magic mushroom campaign group (Sep 1) ↗ Telegraph
August 19 - 25, 2024
What Does FDA Expect from Lykos’ Next Phase 3 MDMA Study? (Part 1) (Aug 22) ↗ Psychedelic Alpha
Opinion: How Psychedelic Research Got High on Its Own Supply (Aug 23) ↗ NYT
FDA Widens Probe of Ecstasy-Based Drug Studies (Aug 23) ↗ WSJ
FDA’s Lykos Rejection Delays—But Doesn’t Stop—Psychedelic Therapies (Aug 19) ↗ BioSpace
Psychedelic Drugs May Give a Glimpse Into Near-Death Experiences (Aug 22) ↗ NYT
How a U.S. Navy veteran found healing in psychedelics (Aug 21) ↗ Axios Boston
What to know about Massachusetts’ psychedelics ballot question (Aug 21) ↗ Axios Boston
It’s not just psychedelics that change minds, says Michael Pollan. Storytelling does, too. (Aug 23) ↗ UC Berkeley News
Staring down death, he started the battle of his life. How Thomas Hartle helped change Canada’s approach to psychedelics (Aug 19) ↗ Toronto Star
Natural Medicine Advisory Bulletin 13.5: The Birth of a Regulated Psychedelics Program (Aug 20) ↗ Psychedelic Alpha X Vicente LLP
A must-read for anyone considering operating a Natural Medicine Business, or becoming a Facilitator, in Colorado’s state-regulated psychedelics program.
‘From LA to Byron to Sydney’: The trippy treat popular among Millennial mums (Aug 21) ↗ The Sydney Morning Herald
A look into Aaron Rodgers’ psychedelic journey: How the NFL star got into Ayahuasca (Aug 20) ↗ Marca
Arizona researcher says medical psychedelics need more science, less hype (Aug 19) ↗ KJZ
August 12 - 18, 2024
Breaking: Lykos Lays Off 75% of Staff, Ropes In Pharma Veteran, Doblin Resigns Board (Aug 15) ↗ Psychedelic Alpha
Pα+ Psychedelic Bulletin #170 (Aug 15) ↗ Psychedelic Alpha
- MindMed Tops Up Healthy Cash Balance with $75M Raise; Eyes Adding Depression to Pipeline?
- atai Approaches Phase 2 for DMT and R-MDMA Candidates
- Compass’ Phase 3 Program Generally On-Track, Potential for Slight Delay on Readout
- European Psychiatrists Remain Open to Psychedelics, Research
- Other Stories, including: Cybin’s Phase 3 plans; AbbVie’s $8.7bn neuropsych acquisition; Otsuka’s DTx pricing; Intra-Cellular Therapies’ preferred non-hallucinogenic lingo; Gilgamesh’s Fierce 15 spot; Incannex’s green light from FDA; and more.
Rick Doblin, ‘unleashed,’ blasts FDA over Lykos drug rejection and turns to global push for MDMA therapy (Aug 17) ↗ STAT
The Promise and Future of Psychedelics Research (Aug 16) ↗ NPR (49 mins)
LYKOS-RELATED HEADLINES
Q&A: Lykos just cut 75% of its workforce after an FDA rejection. Here’s what the CEO has to say (Aug 16) ↗ Endpoints
Endpoints puts some tough questions to Lykos CEO Amy Emerson.
Where does MDMA-assisted therapy go from here? (Aug 15) ↗ The Week
MDMA Treatment for PTSD Fails to Secure Federal Approval (Aug 13) ↗ Smithsonian Magazine
Psychedelic advocates in Oregon criticize FDA’s decision to reject MDMA therapy for PTSD (Aug 15) ↗ OPB
Opinion FDA ruling on ectasy for PTSD is a bad trip for suffering patients (Aug 15) ↗ WaPo
OPEN WAR As FDA BLOCKS MDMA Therapy For Vets (Aug 15) ↗ YouTube (Breaking Points)
In a fiery interview, Jonathan Lubecky goes toe-to-toe with former Psymposia Managing Editor David Nickles.
FDA’s Rejection of MDMA Psychotherapy for Trauma Draws Criticism from Psychedelic Experts (Aug 13) ↗ Scientific American
No, the FDA Didn’t Reject MDMA Therapy Because of Big Pharma—It Was Because of Shoddy Science (Aug 14) ↗ Slate
MDMA-assisted therapy in limbo after several papers retracted over ‘integrity concerns’ (Aug 14) ↗ CNBC
How the next psychedelics companies believe they can avoid Lykos’ fate (Aug 16) ↗ Biocentury
FDA rejection of MDMA-assisted therapy rattles advocates but doesn’t spell end of psychedelics in medicine, experts say (Aug 13) ↗ CNN
FDA rejects ecstasy as a therapy: what’s next for psychedelics? (Aug 13) ↗ Nature
The FDA Didn’t Approve MDMA. Is the Medical System Ready for Any Psychedelic? (Aug 12) ↗ TIME
In a one-two punch for Lykos, 3 articles on MDMA treatment retracted due to unethical conduct (Aug 12) ↗ Fierce Biotech
Three Studies of MDMA Treatment Retracted by Scientific Journal (Aug 12) ↗ NYT
FDA rejected MDMA-assisted PTSD therapy. Other psychedelics firms intend to avoid that fate (Aug 12) ↗ Science
MDMA Papers Retracted for ‘Unethical Conduct’ on Heels of Lykos’ FDA Rejection (Aug 12) ↗ BioSpace
FDA’s Rejection of MDMA for PTSD Could Signal Setback for Psychedelic Industry (Aug 12) ↗ Behavioral Health Business
FDA rejects Lykos MDMA therapy, asks for another Phase III trial (Aug 12) ↗ Clinical Trials Arena
Lykos Plots FDA Appeal: Reeling from CRL and Journal Article Retractions, MDMA Developer Hopes to Change Your Mind (Aug 13) ↗ Psychedelic Alpha
Josh delves into FDA’s appeal process with regard to Lykos Therapeutics’ development program, and covers the trio of journal article retractions that have cast another shadow over the company’s published studies. Plus: We assess the fallout beyond Lykos, as psychedelic drug developers wrestle over the role of psychotherapy in their protocols, fast followers assess their strategies, and would-be psychedelic therapy delivery companies face a substantial delay.
What to know about the 5 people charged in Matthew Perry’s death (Aug 15) ↗ AP News
A prosecutor says five people have been charged in connection with Matthew Perry’s death from a ketamine overdose last year, including the actor’s assistant and two doctors.
See also: Matthew Perry investigation: What we know about the people charged in his death (Aug 15) ↗ LA Times
See also: ‘Shoot Me Up With a Big One’: The Pain of Matthew Perry’s Last Days (Aug 16) ↗ NYT
Hundreds of Israeli Oct. 7 Survivors to Undergo PTSD Treatment Using MDMA (Aug 14) ↗ Haaretz
The Uncertain Path Forward for Psychedelic Medicine (Aug 15) ↗ Wired
Colorado solidifies regulations for psychedelic mushroom growers, manufacturers and therapy centers (Aug 16) ↗ The Denver Post
He Took a Psychedelic to Cure His Addiction. It Was His Last Trip (Aug 14) ↗ Rolling Stone
Education about psychedelics will help Colorado program succeed, providers say (Aug 12) ↗ Colorado Newsline
Recruiting healthy participants for London-based psilocybin study ↗ The Digital Intervention for Psychedelic Preparedness (DIPP) study
If you have 3-5 lifetime psychedelic experiences, minimal meditation experience, and can commit to a 21-day prep course with visits to UCL over a 4-week period, researchers would like to hear from you.
August 5 - 11, 2024
BREAKING: FDA Rejects Lykos Therapeutics’ MDMA-Assisted Therapy For PTSD (Aug 9) ↗ Psychedelic Alpha
FDA has issued a Complete Response Letter (CRL) to Lykos Therapeutics regarding its New Drug Application (NDA) for MDMA-assisted therapy in PTSD, meaning the agency is not prepared to approve it at this time.
Read our breaking coverage for more.
Vibe Check: FDA Set to Decide Future of MDMA-Assisted Therapy This Week (Aug 6) ↗ Psychedelic Alpha
With a target PDUFA date of August 11th, FDA is expected to make a decision on Lykos Therapeutics’ MDMA-assisted therapy for PTSD New Drug Application (NDA) at some point this week.
As we brace for a deluge of mainstream media coverage and insider reactions, Josh takes the opportunity to provide a brief assortment of notes and thoughts.
LYKOS-RELATED HEADLINES
Post-announcement
Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD (Aug 9) ↗ Lykos Press Release
The story has been widely covered in major outlets, including:
- AP: FDA rejects psychedelic MDMA as treatment for PTSD, calling for additional study
- BBC: US drug regulators reject ecstasy for mental health treatment
- NYT: F.D.A. Declines to Approve MDMA Therapy, Seeking More Study
- WSJ: FDA rejects first psychedelic to treat PTSD, calling for more study
- NBC: FDA rejects MDMA-assisted therapy for PTSD
- NPR: FDA gives thumbs down to MDMA for now, demanding further research
- Vox: MDMA therapy didn’t get FDA approval. Now what?
- Biopharma Dive: In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD
- STAT: FDA rejects MDMA as a psychedelic treatment for PTSD
- CNN: FDA declines to approve novel MDMA therapy to treat PTSD, with request for more trial data
- WIRED: The FDA Just Rejected a Bid for MDMA’s Approval to Treat PTSD
- Axios: FDA rejects ecstasy treatment for PTSD
- Bloomberg: FDA Rejects Use of Psychedelic MDMA for PTSD Patients
- Reuters: US FDA declines to approve first MDMA-based PTSD treatment
- Lucid News: FDA Denies the Lykos Therapeutics Application for MDMA-Assisted Therapy
Pre-announcement
Veterans and Lawmakers Lobby in Bipartisan Push for MDMA Therapy (Aug 8) ↗ NYT
MDMA is on the brink of becoming medicine (Aug 8) ↗ Vox
MDMA therapy is facing an imminent FDA decision. Here’s what you need to know (Aug 9) ↗ STAT
Q&A: Bergman on pushing the FDA on psychedelics (Aug 8) ↗ POLITICO
FDA deadline on ecstasy for PTSD prompts lobbying blitz (Aug 7) ↗ Axios
Bipartisan lawmakers press Biden administration on MDMA treatment for PTSD (Aug 5) ↗ The Hill
Ecstasy Drug Trials Missed Suicidal Thoughts of Subjects (Aug 5) ↗ WSJ
There Are No Good Treatments for PTSD. MDMA Can Change That (Aug 7) ↗ TIME
With FDA decision looming, bipartisan group of lawmakers urge support for MDMA to treat PTSD (Aug 5) ↗ CNN
How a 3-star general came to believe in psychedelic medicine (Aug 5) ↗ POLITICO
Lykos’ MDMA-Assisted PTSD Therapy Heads to FDA After Adcomm Setback (Aug 5) ↗ BioSpace
Lawmakers urge the FDA to approve MDMA treatment for PTSD (Aug 7) ↗ Healthcare Brew
How the FDA Could Shape the Future of Psychedelics Research (Aug 5) ↗ Undark
Patients ‘pressured into positive feedback for ecstasy-based drug’ (Aug 6) ↗ The Times
FDA to decide on Lykos’ MDMA therapy for PTSD, offering hope for millions (Aug 6) ↗ Outsourcing Pharma
Three Lykos-Affiliated Studies Retracted (Aug 10)
The journal Psychopharmacology has issued three retraction notices for MAPS/Lykos’ meta-analysis of phase 2 studies of MDMA-assisted therapy for PTSD, which constituted the rationale for a Phase 3 program. The first retraction pertains to the pooled analysis of the half-dozen phase 2 studies (Mithoefer et al., 2019), the second relates to the long-term follow-up of those six trials (Jerome et al., 2020), and the third applies to an analysis of four of the phase 2 studies to explore the effect of tapering antidepressants (Feduccia et al., 2020).
Getting to ‘Plan B’ for psychedelic medicine: Lessons from reproductive health (Aug 11) ↗ STAT
Psychedelic Medicine Has a Therapy Problem (Aug 11) ↗ The Atlantic
The end-of-life patients finding solace in magic mushrooms: ‘What life after life could be like’ (Aug 6) ↗ The Guardian
When Ollie took a pill, he didn’t realise it would be a ‘never-ending trip’ (Aug 9) ↗ The Sydney Morning Herald
New psychedelics medical research centre opening in Kingston, Ont. (Aug 7) ↗ CBC
Inside the underground MDMA couples’ therapy boom (Aug 8) ↗ GQ
Psychedelics as a serious investment? These billionaires think so (Aug 9) ↗ Australian Financial Review
Psychedelic mushroom edibles could soon be legally available in Oregon for the first time (Aug 6) ↗ Oregon Live
Are legal psilocybin truffles the new magic mushrooms? (Aug 9) ↗ The Times
Jack Black felt ‘whole for the first time’ after trying psychedelic drugs at 13 (Aug 6) ↗ FOX News
The Bankrupt Ayahuasca Church Where Negligence Led to Death (Aug 7) ↗ VICE
July 29 - August 4, 2024
Psychedelic Funding Update- Q2 2024 (Aug 1) ↗ Psychedelic Alpha
Podcast: The Future of Bipolar Disorder Treatment With Psychedelics and Neuromodulation (July 30) ↗ Medscape
Psilocybin legislation is helping psychedelic drugs make a comeback – a drug researcher explains the challenges they face (Aug 2) ↗ The Conversation
LYKOS-RELATED HEADLINES
It took more than two decades for MDMA to reach the FDA. In two months, its prospects cracked. What happens next? (Aug 1) ↗ Endpoints
MDMA is on the brink of becoming medicine (Aug 2) ↗ Vox
Can a lobbying push led by veterans help MDMA get approved for PTSD treatment? (Aug 1) ↗ NPR
Lykos Therapeutics Announces New Initiatives and Measures for Additional Oversight for Midomafetamine-Assisted Therapy, if FDA Approved (Aug 1) ↗ Press Release
Religious leaders say legal gray area makes psychedelics standards vital (Aug 1) ↗ SF Examiner
Current, former employees say local psychedelic church left them disillusioned (Aug 1) ↗ SF Examiner
UC Berkeley Center for the Science of Psychedelics and PRX Launch “Altered States,” a New Podcast Traversing the Science and Personal Experience of Psychedelics (Jul 31) ↗ BCSP
July 21 - 27, 2024
This Week’s Feed, Sponsored by…
September 24-26, 2024, Boston, MA
The 7th Neuropsychiatric Drug Development Summit returns as the industry’s only end-to-end gathering, dedicated to innovating precision psychiatry and propelling next-generation drug R&D. Uniting discovery, preclinical, clinical, regulatory, and commercial experts to address the field’s most pressing challenges, join 3-days of forward-thinking discussions and stay up-to-date with new targets, mechanisms, and technologies transforming the mental health treatment landscape.
Pα+ Psychedelic Bulletin #169 (July 26) ↗ Psychedelic Alpha
- Sergey Brin Bets $15M on Ibogaine Startup Soneira, But Questions Loom Over Patents
- Head-to-Head Trial Hopes to Assess Role of Psychotherapy in Psilocybin Treatment
- J&J Seeks FDA Approval of Spravato as Monotherapy
- Other Stories
Could Colorado communities not friendly to medicinal mushrooms put up roadblocks to stymie the industry? (July 22) ↗ The Denver Post
Prop. 122, which called for the creation of a regulated natural medicine (psychedelics) system in Colorado, didn’t permit localities to opt-out, unlike Oregon’s Measure 109. But, locals are finding a way by setting time, place and manner restrictions.
Advocates look toward future for psychedelic-assisted therapy in California (July 25) ↗ Courthouse News Service
FDA weighs approval of psychedelics treatments for PTSD (July 23) ↗ Texas Standard
Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression (July 22) ↗ J&J Press Release
J&J has filed a supplemental NDA (sNDA) with FDA, Seeking Approval of Spravato as a monotherapy for Treatment-Resistant Depression. If approved, the esketamine nasal spray would become the first monotherapy for adults with the depressive disorder.
Adding psychotherapy to drug therapy works, but the FDA may not be able to handle it (July 25) ↗ STAT
Psychedelic drug-aided therapy ‘saved my life,’ SC woman says. The FDA may not approve it. (July 22) ↗ The Post and Courier
FDA Talks Help Cybin Advance Two Psychedelic Drugs Toward Approval (July 26) ↗ Clinical Leader
Veterans lobbied for psychedelic therapy, but it may not be enough to save MDMA drug application (July 26) ↗ AP News
UNM Health Sciences Researchers to Test Psychedelic Drugs as Treatments for Depression, PTSD and More (July 22) ↗ UNM Health Sciences
Mushroom edibles are tripping up users (July 24) ↗ The Week
Frisco looks at regulating ‘healing centers’ where ‘natural medicines’ like psychedelic mushrooms can be given to patients (July 26) ↗ Summit Daily
The DEA Wants To Ban Scientifically ‘Crucial’ Psychedelics Because People Might Use Them (July 23) ↗ Reason
See also DEA’s Move To Ban Two Psychedelics Is Challenged As A ‘Disservice To Science’ In Legal Filing From Student Group (July 24) ↗ Marijuana Moment.
Why are there 17 pairs of Army boots lined up outside the White House? The answer has to do with PTSD — and psychedelic drugs (July 26) ↗ WTOP
Psychedelic couples therapy transformed my relationship with my partner (July 27) ↗ Glamour
July 16 - 21, 2024
Regulation Beyond Prohibition: RAND Corporation Delivers Report on US Psychedelic Policymaking (July 16) ↗ Psychedelic Alpha
A psychedelic state arises from desynchronized brain activity (July 17) ↗ Nature News
Coverage of Siegel et al.’s new study, Psilocybin desynchronizes the human brain, published in Nature on Wednesday. The paper was widely covered elsewhere, including in The New York Times.
Google co-founder backs biotech studying psychedelic African shrub (July 21) ↗ Financial Times
In strengthening Spravato sales, a positive sign for psychedelic drugs (July 17) ↗ Biopharma Dive
FDA investigators have not spoken with patients and others alleging misconduct in MDMA trials (July 19) ↗ STAT
Pα+ Psychedelic Bulletin #168 (July 19) ↗ Psychedelic Alpha
- California’s Psychedelic Research Bottleneck Ends Today
- Letter to the Editor: Neşe Devenot
- A Look at Complaints as Oregon Psilocybin Services Turns One
- Disability and Psychedelics
- Other Stories
Semel Institute rooftop to be reborn as plant-filled living laboratory (July 15) ↗ UCLA Health
“…the top deck of the Semel Institute is being reimagined as a state-of-the-art living laboratory to study Ecological Medicine and psychedelic therapies. It will be the first of its kind in a biomedical setting.”
See also: Calif. university wants to build a rooftop garden for taking psychedelic drugs (July 17) ↗ SF Gate
Defying Industry Setbacks, MindMed Advances Psychedelic To Phase 3 (July 17) ↗ Clinical Leader
At a progressive Christian festival in the woods of North Carolina, psychedelics were top of mind (July 16) ↗ Religion News Service
The Unbelievable Claims of Psymposia about MAPS and MDMA-Assisted Therapy (July 19) ↗ Chacruna
As FDA weighs use of MDMA, Texans push to destigmatize psychedelic treatments for PTSD (July 17) ↗ Express News
How should we sell psychedelics? (July 21) ↗ Vox
Opinion: Psychedelic drugs have great therapeutic benefit – if understood on their own terms (July 15) ↗ The Guardian
Psychedelic therapy with ketamine aims to ease PTSD for Ukrainian soldiers coming back scarred from front-line fighting (July 21) ↗ Business Insider
MDMA for dogs? 4 ideas (and one big concern) from CU Denver’s new psychedelic research center (July 15) ↗ CPR
July 8 - 15, 2024
Pα+ Psychedelic Bulletin #167 (July 12) ↗ Psychedelic Alpha
- Lykos Insiders, Affiliates, Respond to Critics
- Might FDA Miss Its August 11th Goal Date?
- FDA-Affiliated Workshop Discusses Ketamine’s Use In Mental Health Treatment
- Colorado’s Regulated Psychedelics System Takes Shape; Last Chance for Public Comment
- EMA Reps Recap Psychedelics Workshop
- Other Stories
Dutch Committee Seeks to Expedite MDMA-Assisted Therapy for PTSD (July 9) ↗ Psychedelic Alpha
Should Mass. legalize psychedelic mushrooms? (July 12) ↗ Boston.com
Natural Medicine Advisory Bulletin 12: May and June 2024 (July 8) ↗ Psychedelic Alpha X Vicente LLP
Vicente LLP walk us through more than a dozen hearings, meetings and (proposed) rule updates since our last Bulletin. As we head into a month that features final public hearings on a number of matters, now is the time to make your voice heard.
Is psychedelic therapy about to go mainstream? (July 8) ↗ SwissInfo
Some moms are microdosing on mushrooms, touting the benefits – but risks exist, say doctors (July 10) ↗ FOX News
U.S. lawmakers, advocates ask FDA to approve use of psychedelics for PTSD treatment (July 11) ↗ Michigan Advance
Lessons to learn from Oregon on psychedelics ballot measure (July 8) ↗ Commonwealth Beacon
What happened to UK’s first ketamine-assisted clinic? (July 12) ↗ BBC
The BBC looks at what happened to Awakn’s Bristol clinic. TL;DR: There weren’t enough patients able or willing to afford the out-of-pocket costs for treatment courses.
Mapping the brain’s visual world on psychedelics, texture and time (July 12) ↗ Allen Institute
A World-First Psychedelics Experiment Is Unfolding in Australia (July 8) ↗ Bloomberg
Microdosing mushroom candies linked to illness in Oregon, 26 other states (July 10) ↗ Oregon Live
July 1 - 7, 2024
Pα+ Psychedelic Bulletin #166 (July 5) ↗ Psychedelic Alpha
In this Issue:
- Dan Crenshaw and Elon Musk Add Fuel to Lykos ‘Dumpster Fire’ Drama
- ‘They Not Like Us’ — Psychedelic Drug Developers Emphasise Avoidance of Lykos’ Perceived Pitfalls
- Mini Interview: Joshua Ismin, Psylo
- Other Stories
Psychiatric Drug Developers Make Recommendations Following Lykos Adcomm (July 1) ↗ BioSpace
Funding the Future of Psychedelic Medicine in Europe: An Interview with Norrsken Mind (July 3) ↗ Psychedelic Alpha
Is a Drug Even Needed to Induce a Psychedelic Experience? (July 3) ↗ Scientific American
Depression Is Notoriously Difficult to Treat. Can Psychedelic Therapies Help? (July 1) ↗ BioSpace
Mexico has become a testing ground for psychedelic therapies (July 4) ↗ The Economist
Psychedelic mushroom edibles promise health benefits. Be wary, experts say. (July 4) ↗ WaPo
The Psychedelic Renaissance and the Veterans Leading the Charge (July 5) ↗ Austin Chronicle
Two reasons I’m sceptical about psychedelic science (July 1) ↗ The Conversation
June 24 - 30, 2024
Pα+ Psychedelic Bulletin #165:
- A Closer Look at a Buzzy Oral Ketamine for Depression Study;
- UN Weighs In on Psychedelics;
- Another CA Psychedelics Bill Fails
and more…
(June 28) ↗ Psychedelic Alpha
Video: Will Psychedelics Go Mainstream? (June 23) ↗ The Aspen Institute
UN World Drug Report Comments on ‘Developments Around Psychedelics’ (June 26) ↗ PDF
Considering Alternatives to Psychedelic Drug Prohibition (June 27) ↗ RAND
RAND has published a 161-page report on the state of non-medical psychedelic use in an effort to inform policymakers in the U.S. and beyond. Psychedelic Alpha is pleased to be cited as a source of data and analysis in the piece.
Don’t write off MDMA yet: How the FDA got on board with psychedelics (June 28) ↗ STAT
In Brief: ICER Issues Final Evidence Report and Recommendations Re: MDMA-Assisted Therapy; Lykos Responds (June 27) ↗ Psychedelic Alpha
Turning a ‘no’ vote into progress: How to advance MDMA-assisted psychotherapy for PTSD (June 25) ↗ STAT
Oregon sued over access to magic mushrooms (June 25) ↗ Portland Business Journal
“The plaintiffs are challenging OHA’s “failure to ensure” that the psilocybin program doesn’t discriminate against physically disabled individuals.”
Mexico may legalize magic mushrooms. Will this traditional medicine lose its meaning? (June 25) ↗ LA Times
Psylo partnership to deliver psychedelic treatments for mental health (June 27) ↗ University of Sydney
CU Denver Launches Psychedelic Research Center in Downtown Denver (June 24) ↗ CU Denver
California Drops Psychedelic Therapy Legalization Bill, Again (June 25) ↗ KQED
Advocates and providers aim to lower cost of psilocybin treatment (June 26) ↗ Axios
Health Canada provides legal access to psilocybin for first cluster headache patient ↗ OPIS
“Canada now joins Switzerland as one of the few countries where cluster headache patients have been explicitly authorised to use psychedelics outside of clinical trials”, said the Organisation for the Prevention of Intense Suffering (OPIS).
Ketamine pills for depression show positive results in trial—but with caveats (June 25) ↗ Ars Technica
Professional Guidelines Needed To Shape Ethics of Psychedelic Use in Psychiatry (June 25) ↗ Psychiatric News
“We are going to have to regulate ourselves, and our professional organizations have a role to play in developing guidelines to help clinicians,” Paul Appelbaum said.
Lieberman & Kennedy: Psychedelics worth pursuing, with care (June 26) ↗ Boston Herald
In-home psilocybin use should be allowed in Oregon for disabled and terminally ill people, lawsuit says (June 26) ↗ Oregon Live
June 17 - 23, 2024
No NHS Coverage for Janssen’s Spravato: NICE Denies Re-Appraisal of Esketamine for TRD (June 21) ↗ Psychedelic Alpha
In Conversation: Joanna Kempner, Author of “Psychedelic Outlaws: The Movement Revolutionizing Modern Medicine” (June 18) ↗ Psychedelic Alpha
Podcast: FDA’s Advisory Committee says no to MDMA. What’s the impact? With Josh Hardman (June 21) ↗ Business Trip
“Greg and Matias interview Josh Hardman, founder and editor of Psychedelic Alpha, to discuss the recent FDA advisory committee meeting on Lykos Therapeutics’ MDMA-assisted therapy for PTSD.”
Summer School: Far from Far Out: Policy Perspectives on the Psychedelic Renaissance (Begins Jul 8, Registration Open) ↗ Stanford Continuing Studies
Laurel Kilgour’s 6-week online summer course via Stanford Continuing Studies returns to provide an overview of topics like psychedelic patents, monopolisation risks, ethical implications of commercialising plant medicine, and so on.
UC Berkeley Launches Landmark Study: How Exactly Do Magic Mushrooms Alter the Brain? (June 18) ↗ KQED
Lykos Confident That Working With FDA Will Merit MDMA-AT Approval (June 20) ↗ Lucid News
The biggest unknown in psychedelic therapy is not the psychedelics (June 19) ↗ Vox
FDA advisors voted against MDMA therapy – researchers are still fighting for it (June 20) ↗ BBC Future
Push for psychedelics is redoubled (June 18) ↗ Axios
June 10 - 16, 2024
Breaking: Lykos Therapeutics Moved to Patent MDMA In Late 2022, Filing Reveals (June 13) ↗ Psychedelic Alpha
Pα+ Psychedelic Bulletin #164:
- Lykos Dominates News Cycle;
- EPIsoDE Trial Readout;
- EU Drug Report Discusses Psychedelics;
- DEA Should Improve RFRA Petition Process;
- Other News
(June 14) ↗ Psychedelic Alpha
The FDA Might Reject MDMA Therapy—but Not for the Reasons You Think (June 13) ↗ Slate
With MDMA debate spreading beyond biotech, Lykos CEO tries to dispel efficacy, safety concerns (June 13) ↗ Fierce Biotech
Trouble for ecstasy? What MDMA’s FDA setback could mean for psychedelics (June 13) ↗ NPR
Pα+ Analysis: FDA Advisory Committee Snubs MDMA-Assisted Therapy for PTSD in Overwhelming “No” Vote (June 11) ↗ BioSpace
‘Suicide headache’ patient granted magic mushroom access after Health Canada u-turn (June 12) ↗ National Post
Despite adcomm rejection, Lykos CEO sees future for MDMA drug (June 12) ↗ PharmaVoice
Psychedelic Therapies Could Soon Break Through Against Addiction (June 10) ↗ BioSpace
GOP Congressman Who Used Psychedelics For Mental Health Slams FDA Panel’s MDMA Rejection (Op-Ed) (June 13) ↗ Morgan Luttrell
Oregon Threatens to Revoke Approval of a Mushroom School That Says It’s a Religious Practice (June 12) ↗ Willamette Week
Oregon’s psilocybin industry, a year old, seeks customers (June 10) ↗ Oregon Capital Chronicle
MDMA therapy for PTSD treatment? FDA panel says no (June 11) ↗ KCRW
Reeling from FDA setback, researchers plot the future of psychedelic-assisted medicine (June 11) ↗ Science
Magic mushrooms helped a Navajo woman deal with trauma. Now she wants to help others (June 12) ↗ The Guardian
Psychedelic drugs ‘overhyped as miracle cures’ (June 10) ↗ The Times
FDA panel rejects MDMA-assisted therapies for PTSD despite high hopes from veterans (June 13) ↗ Fox News
Psychedelics change how we see the world. A UC Berkeley study aims to find out why. (June 11) ↗ Berkeley News
June 3 - 9, 2024
LIVE COVERAGE
Follow our Live Coverage of FDA’s MDMA Advisory Committee (June 4) ↗ MIT Technology Review
POST-ADCOMM MAINSTREAM COVERAGE
The psychedelic medicine revolution just took a big loss (June 4) ↗ POLITICO
Psychedelics companies see FDA panel’s vote as a growth opportunity, not a roadblock (June 6) ↗ STAT
MDMA-Maker Failed Its FDA Hearing — And Its PTSD Patients (June 5) ↗ Bloomberg
After FDA setback, psychedelic drugmakers distance themselves from a pioneer (June 8) ↗ WSJ
After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next (June 7) ↗ Biopharma Dive
In a setback for psychedelic therapy, FDA advisers vote against medical use of ecstasy (June 5) ↗ Science
Panel rejects psychedelic drug MDMA as a PTSD treatment in possible setback for advocates (June 5) ↗ AP News
INSIDERS REACT TO ADCOMM
MAPS / Lykos: who is to blame and what happens next? (June 8) ↗ Ecstatic Integration
Can MDMA-AT Be Saved? (June 5+) ↗ The Frontier Psychiatrists
Breaking News: F.D.A. Panel Votes Against MDMA-Assisted Therapy for PTSD (June 5) ↗ The Microdose
Perspective: FDA Advisory Committee vote on MDMA-AT (June 6) ↗ Liana Sananda Gillooly
PRE-ADCOMM COVERAGE
Landmark review spotlights challenge of judging psychedelic therapies (June 3) ↗ Axios
Psychedelics Are Challenging the Scientific Gold Standard (June 3) ↗ The Atlantic
Could psychedelic toads boost our brains? London scientists launch trial into substance found on amphibian’s skin (June 3) ↗ The Standard
The FDA may approve psychedelics for treating PTSD. Here’s what to know (June 3) ↗ Quartz
What’s next for MDMA (June 3) ↗ MIT Technology Review
Lykos’ MDMA-Assisted Therapy Faces Landmark Adcomm (June 3) ↗ BioSpace
Misconduct claims may derail MDMA psychedelic treatment for PTSD (June 3) ↗ NPR Short Wave (Audio)
Some psychedelic medicine developers want to ditch the therapy aspect. What could go wrong? (June 7) ↗ Salon
How ‘Selling Out’ helped psychedelic MDMA (June 3) ↗ Mercury News
From Toad Toxin to Medicine: The Promise of 5-MeO-DMT (June 3) ↗ Undark
Could psilocybin change a young mother’s cancer journey? Inside Colorado’s major psychedelic study (June) ↗ CPR News
Adam’s son died in the Hunter Valley bus crash. In a NSW first, he’ll try MDMA to ease his anguish (June 3) ↗ The Sydney Morning Herald
I have lifelong anorexia. MDMA and mushrooms showed me remission is possible (June 5) ↗ The Guardian
May 27 - June 2, 2024
This Week’s Feed, Sponsored by
Clerkenwell Health, a specialised psychedelic research organisation, has opened enrolment for their Psychedelic Practitioner Foundations Programme, a course aimed at all healthcare professionals to prepare them with the skills and knowledge required to safely, ethically, and effectively deliver psychedelic treatments in the future.
Pα+ ICER Panel Rejects MDMA-Assisted Therapy, Highlights Evidence Gaps and Study Flaws in 14-1 Vote (May 31) ↗ Psychedelic Alpha
Pα+ Patients, Practitioners, Researchers and Public Submit Comments Ahead of FDA Advisory Committee on MDMAD (May 29) ↗ Psychedelic Alpha
Meeting materials available for Tuesday’s FDA advisory committee on MDMA-assisted therapy. ↗ FDA
Can psychedelics treat depression? Maybe, and you might not even have to take a trip (Jun 1) ↗ The Guardian
PTSD Has Surged Among College Students (May 30) ↗ NYT
“The prevalence of post-traumatic stress disorder among college students rose to 7.5 percent in 2022, more than double the rate five years earlier, researchers found.”
Pα+ What to Expect: FDA Advisory Committee Set to Review MDMA-Assisted Therapy for PTSD (May 27) ↗ Psychedelic Alpha
The Long Road Toward Equitable MDMA Treatment in the United States (May 29) ↗ Psychiatrist.com
uOttawa launches groundbreaking MA in Psychedelics & Consciousness Studies (May 29) ↗ uOttawa
Psychoactive drugs like ketamine and MDMA are having a moment. The FDA will soon weigh in. (May 28) ↗ CBS News
An Academic Shroom Boom (May 30) ↗ Oprah Daily
MDMA-AT COVERAGE RAMPS UP AHEAD OF FDA ADCOMM
A variety of mainstream outlets are running stories on Lykos Therapeutics’ upcoming FDA advisory committee, slated for next Tuesday.
FDA Staff Raises Concerns About Ecstasy Drug’s Safety in Report (May 31) ↗ Bloomberg
F.D.A.’s Review of MDMA Cites Health Risks and Study Flaws (May 31) ↗ NYT
What to watch for in the crucial FDA meeting on MDMA therapy for PTSD (May 31) ↗ STAT
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD (May 31) ↗ WaPo
The battle for MDMA as drug steps closer to becoming a prescription medicine (May 31) ↗ Independent
What to watch for in the crucial FDA meeting on MDMA therapy for PTSD (May 31) ↗ STAT
Illegal Ecstasy Takes Step Toward Becoming Legal Drug for PTSD (May 30) ↗ Bloomberg
May 20 - 26, 2024
Pα+ Psychedelic Patent Analysis: April 2024 (May 24) ↗ Psychedelic Alpha
This month:
- A CaaMTech & ASRI Collaboration
- GH Research & Beckley Psytech: An Update
- CaaMTech Grows Tryptamine Patent Portfolio
- Atai Sees Two New Allowances to Support DMT Program
Psychedelic-assisted therapy in the treatment of addiction (May 21) ↗ UK Parliamentary Office of Science and Technology
The traumatised police officers flying to Peru to take psychedelics (May 23) ↗ The Telegraph
Inside the breathtaking world of therapeutic psychedelics: Great promise and great challenges (May 22) ↗ Fierce Healthcare
Fluence Launches Generative AI Tools for Psychedelic Therapist Training (May 21) ↗ Press Release
A patchwork of state-level psychedelic medicine legislation raises equity concerns (May 24) ↗ Healthcare Brew
IBEX011, the first Nagoya-compliant GMP iboga extract, is now available for clinical use and academic research (May 20) ↗ Press Release
Equitable Access, Healing Trauma, and Shifting Public Opinion: Highlights from the “Horizons” Conference (May 21) ↗ BCSP
Could microdosing with psychedelics help treat depression? (May 23) ↗ The Irish Times
After MDMA therapy, she considered suicide. The trial data tell a different story (May 24) ↗ STAT
May 13 - 19, 2024
This Week’s Feed, Sponsored by…
May 23-24, Boston
The 4th Annual Psychedelic Therapeutics & Drug Development Conference offers a unique opportunity to delve into the rapidly evolving field of psychedelic science and its potential in healthcare. Plenary talks and panel sessions will see a wide range of topics covered including drug scheduling, the future of psychedelic science, clinical trial design, research protocols, pain and psychedelics and precision medicine in mental health care.
Pα+: Psychedelic Bulletin #163: Tempering Excitement Around Recent Raises; Compass Shares Cut of Open-Label PTSD Data; Other News (May 17) ↗ Psychedelic Alpha
Industry and Researchers Respond to ICER Report on MDMA-Assisted Therapy, Which Maintains Lykos’ Clinical Evidence Is “Insufficient” (May 14) ↗ Psychedelic Alpha
Pα+: Breaking: AbbVie Inks Deal with Gilgamesh Pharmaceuticals (May 13) ↗ Psychedelic Alpha
“We’re Going to See Demand for This Go Through the Roof”: VA Under Secretary for Health Shares How the Agency Is Preparing for MDMA, Psilocybin Therapies (May 15) ↗ Psychedelic Alpha
Lucid News Salutes Our Friend Ken Jordan (May 14) ↗ Lucid News
“The staff of Lucid News is deeply saddened by the death on Sunday of our friend and colleague Ken Jordan. In addition to being our Editorial Director and co-founder of Lucid News, Ken was a true pioneer and leader in the psychedelic movement and a dear friend to many of us. He had a clear vision of the future of psychedelic communities and dedicated his life to the transformative power of psychedelics for worldwide healing.”
We at Psychedelic Alpha share in this deep sadness. If you would like to honour Ken’s legacy, please consider donating to Lucid News.
Woman free of anxiety meds 1 year after Cleveland Clinic LSD trial success (May 15) ↗ Cleveland.com
Psychedelics could treat some of the worst chronic pain in the world (May 15) ↗ Vox
California’s Latest Psychedelics Bill Dies in Committee (May 17) ↗ Psychedelic Alpha
California’s new magic mushroom team (May 13) ↗ POLITICO
Expand your mind with a new magazine of psychedelic art and literature. (May 13) ↗ Literary Hub
Franklin King, MD: Psychedelic Therapy History, Advances, and Hurdles (May 13) ↗ HCP Live
MDMA therapy could be legalized by summer. Why are so many advocates sounding the alarm? (May 13) ↗ Business Insider
MAPS (the nonprofit) issued a statement in response.
Srinivas Rao to Take the Reigns as atai Life Sciences CEO by Year-End, Replacing Florian Brand (May 15) ↗ Press Release
Amazonian Chief At UN To Combat Traditional Knowledge Piracy (May 14) ↗ International Business Times
“A psychoactive brew prepared from vines by the people of the western Amazon basin, ayahuasca is seen, depending on the version, as a miracle cure, a tool for inner exploration and personal development, a recreational hallucinogen, or a dangerous psychotropic drug.”
As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidence (May 13) ↗ NPR
May 6 - 12, 2024
A message from our friends…
June 5, Haarlem (the Netherlands)
The Pathways to Access Summit (Paths) takes place a day prior to ICPR in Haarlem, the Netherlands. The full-day Summit convenes key stakeholders from Europe and beyond to explore the opportunities and challenges around the development, approval, and eventual integration of psychedelic medicines into mainstream European health care.
Use code PA100 for €100 off your Paths ticket
Pα+: European Medicines Agency CMO Talks Psychedelics and Their Therapeutic Use in Live Q&A (May 9) ↗ Psychedelic Alpha
Pα+: FDA Advisory Committee to Review Lykos Therapeutics’ MDMA-Assisted Therapy in Early June (May 7) ↗ Psychedelic Alpha
Next month, the first psychedelic-assisted therapy will be put before an FDA Advisory Committee as Lykos Therapeutics’ MDMA-AT gets a June 4th slot.
Research Briefing: Toad psychedelic points to biological target for antidepressants (May 8) ↗ Nature
Podcast Episode: The Power and Promise of Psychedelics in Therapy (May 9) ↗ The Assignment with Audie Cornish (CNN)
Drugs, Sacraments or Medicine? Psychedelic Churches Blur the Line. (May 12) ↗ NYT
Lululemon Scion JJ Wilson Plots to Make Psychedelic Drugs the New Yoga (May 12) ↗ The Daily Beast
Australian Federal Government Funds Trial of MDMA-Assisted Therapy for Individuals Affected by Northern River Floods (May 10) ↗ Psychedelic Alpha
Welcome to the Age of Psychedelic Inequality (May 7) ↗ The Nation
“Psychedelic-assisted therapies have been hailed as the wave of the future. They’re also becoming big business. What if most people can’t afford them?”
Weed changed this California town. Now artsy residents are all in on psychedelics (May 8) ↗ LA Times
Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder (May 8) ↗ Press Release
The VA’s high hopes for psychedelics (May 10) ↗ POLITICO
California makes moves toward legalizing psychedelic therapies, like Oregon (May 11) ↗ Oregon Live
First Responders, Veterans Hail Benefits of Psychedelic Drugs as California Debates Legalization (May 9) ↗ California Healthline
The Church of the Eagle and the Condor Settles with Federal Agencies, Can Continue Importing and Using Ayahuasca (May 8) ↗ Psychedelic Alpha
Cultivating Connections: Ecological Medicine Meets Psychedelic Therapies (Event: May 10) ↗ UCLA Ecological Medicine & Psychedelic Studies Initiative
GoDaddy Founder Bob Parsons Opens Up About Trauma and Leadership in ‘Fire in the Hole’ Memoir (May 7) ↗ Inc.
“I am in favor of legalization of all drugs, primarily psychedelics. If it takes having psychedelics legalized for therapeutic use, then I’m all in for that also.”
The State of Psychedelics (May 6) ↗ Oprah Daily
“The idea that all of a sudden, wow, instead of having to take a pill every day, a single dose of psilocybin or MDMA could have this profound effect on a chronic illness—it’s pretty cool,” said former NIMH Director Thomas Insel.
Ohio State commencement speaker says he took psychedelics to write Bitcoin speech (May 8) ↗ The Hill
April 29 - May 5, 2024
This Week’s Feed, Sponsored by…
May 23-24, Boston
The 4th Annual Psychedelic Therapeutics & Drug Development Conference offers a unique opportunity to delve into the rapidly evolving field of psychedelic science and its potential in healthcare. Plenary talks and panel sessions will see a wide range of topics covered including drug scheduling, the future of psychedelic science, clinical trial design, research protocols, pain and psychedelics and precision medicine in mental health care.
EXCLUSIVE
Therapists and Trialists from Lykos’ Phase 3 MDMA-Assisted Therapy Studies Push Back on ICER’s Critical Draft Report (Apr 29) ↗ Psychedelic Alpha
Reunion Neuroscience Gets a New Lease of Life with $103M Series A to Fund Phase 2 Studies of 4-HO-DiPT Prodrug (May 3) ↗ Psychedelic Alpha
Gilgamesh Announces Initiation of Phase 2a Trial of GM-1020 in Major Depressive Disorder (May 1) ↗ Press Release
See NCT06309277 for more.
Rick Doblin Featured in TIME100 Health (May 2) ↗ TIME100 Health
“I feel incredibly lucky to see the change that I’ve been working for happen in my own lifetime,” Doblin says. “I can die happy, whenever that comes around.”
Lismore to host clinical trial using MDMA, nature therapy to treat disaster-induced PTSD (May 3) ↗ ABC News
“The [Australian] federal government will spend $3.8 million on the trial involving about 200 survivors of the record-breaking floods that hit the region in 2022.”
A champion of psychedelics who includes a dose of skepticism (May 4) ↗ LA Times
“Ernesto Londoño’s memoir ‘Trippy’ explores psychiatry’s renewed flirtation with drugs such as LSD. He’s a believer but not a zealot.”
For more, read Josh’s interview with Londoño.
I was angry, aggressive and in chronic pain – then a party drug changed everything (May 4) ↗ Metro
Impact Investing in Psychedelics (May 4) ↗ SOCAP 2023 (YouTube)
Compass Pathways establishes research collaborations with Journey Clinical (Apr 29) ↗ Press Release, Mindful Health Solutions (May 2) ↗ Press Release
The longest, strangest trip: Some psychedelic drug users are stuck with unwelcome highs (Apr 30) ↗ LA Times
“A rare condition called hallucinogen persisting perception disorder has puzzled researchers and raised alarms as psychedelics go mainstream.”
Coalition forming to oppose psychedelics ballot question, argues home-grow is unsafe (May 2) ↗ Boston Herald
On this public day on psychedelics, researchers transcend the media hype (Apr 29) ↗ Universiteit Leiden
$3.8 million to help Northern Rivers community heal after 2022 floods (May 3) ↗ Australian Minister for Health and Aged Care
“The stepped care treatments in this clinical trial will include an arts-based group compassion program and group-based MDMA-assisted therapy. It is hoped the findings will provide additional treatment options for those impacted by future disasters.”
The Hopkins-Oxford Psychedelics Ethics (HOPE) Working Group Consensus Statement (May 2) ↗ The American Journal of Bioethics
US poised to ease restrictions on marijuana in historic shift, but it’ll remain controlled substance (May 1) ↗ AP News
Bob Nelsen on megarounds, Altos and psychedelics (May 1) ↗ Fierce Biotech
“Psychedelics are included, a field that Nelsen said ARCH has an interest in. He said that there’s more scientific rigor needed to really dig into how psychedelics work but that the mechanisms of action are intriguing.”
UW’s “magic mushroom” trial advancing (Apr 30) ↗ Axios
Doors of experience: Can psychedelics and meditation solve our problems? (May 3) ↗ Times Literary Supplement
The Rise of Psychedelic Gummies (May 5) ↗ Forbes
PSYCHEDELIC PATENT ANALYSIS
Pα+ Psychedelic Patent Analysis: March 2024 (Apr 30) ↗ Psychedelic Alpha
- First Look at Nolan Williams et al.’s Ibogaine IP: Is Co-Administration of Magnesium and Ibogaine Common Practice?
- Clexio Biosciences Protects CLE-100 Development Programs
- Broad Strokes Attempt from Axsome Fails to Overcome Prior Art
- NYU Abandons “Hot Psilocybin Patent Garbage”
Natural Medicine Advisory Bulletin 11: March & April 2024 (Apr 29) ↗ Psychedelic Alpha X Vicente LLP
Do dying people have a ‘right to try’ magic mushrooms? 9th Circuit weighs case (May 1) ↗ LA Times
Next-generation psychedelic workers (May 1) ↗ POLITICO
A Path Toward Parity: Ensuring Equitable Access to Psychedelic-Assisted Therapy (Apr 29) ↗ BrainFutures
BrainFutures’ latest report “focuses on the critical intersection between the Mental Health Parity and Addiction Equity Act (MHPAEA) and psychedelic-assisted therapy (PAT), offering insights into how this law can help pave the way for comprehensive insurance coverage and access to PAT for those who stand to benefit.”
Magic mushrooms effective for treating depression – study (May 2) ↗ Sky News
Peggy Mellon Hitchcock, Who Helped Timothy Leary Turn On, Dies at 90 (May 2) ↗ The New York Times
“She was an enthusiastic supporter of the counterculture. And when she suggested that her brothers rent Mr. Leary a mansion, she made psychedelic history.”
Magic mushrooms ‘more effective for treating depression in pensioners than young people’ (May 2) ↗ The Telegraph
April 22 - 28, 2024
May 8-11, New York City
Horizons’ 16th Conference comes to NYC next month. Set in the New York Academy of Medicine, the event explores the many dimensions of psychedelics including science, medicine, policy, business, culture, and spirituality.
Pα+ Psychedelic Bulletin #162: EQUULUS Therapeutics Emerges from Stealth; Responses to ICER’s Draft Evidence Report on Lykos’ MDMA; and more… (Apr 25) ↗ Psychedelic Alpha
NEW NIH FUNDING OPPORTUNITY
Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (Opens September 10, 2024) ↗ NIH
Lykos Therapeutics Announces Completion of European Phase 2 Study for MDMA-Assisted Therapy for PTSD (Apr 24) ↗ Press Release
“By pursuing FDA approval of MDMA-assisted therapy first, we believe the learnings will be beneficial as we determine our regulatory strategy in the United Kingdom and Europe”, said Lykos CEO Amy Emerson.
In psychedelic therapy, clinician-patient bond may matter most (Apr 22) ↗ OSU News
PTSD crisis looms as troop shortages take toll on Ukrainian soldiers’ mental health (Apr 25) ↗ Kyiv Independent
“Hibadulin said his condition impeded his relationships and education, and that the only treatment that proved effective for him was psychedelic-assisted psychotherapy – a controversial method to cure PTSD illegal in Ukraine but used to a limited extent in some Western countries.”
Inside Alberta’s promising psychedelic-assisted therapy industry (Apr 27) ↗ CTV News
Insights from the European Medicines Agency’s Psychedelics Workshop: A Pα+ Dispatch (Apr 23) ↗ Psychedelic Alpha
Josh explores some of the key themes discussed at the workshop: from regulatory remits and rescheduling through to disentangling pharmacotherapy from psychotherapy, standardisation and its discontents, blinding, and much more.
The Church of the Eagle and the Condor Reaches a Settlement with Federal Agencies Affirming the Religious Right to Use Ayahuasca (Apr 22) ↗ Press Release (via Chacruna)
“CEC is the first non-Christian church to receive protection for its spiritual practices regarding Ayahuasca.”
Tech bros love talking about microdosing – but the legality of psychedelics is a messy grey area (Apr 26) ↗ The Independent
From politics to the lab: The push for psychedelics in Mass. (Apr 23) ↗ WBUR
MDMA trials are showing it has promise as a psychiatric medicine (Apr 26) ↗ Guardian
“Readers respond to a letter which said that MDMA is not helpful in mental health care”
Nine Lawmakers Ask VA to Report on Its Preparations for MDMA Approval (Apr 23) ↗ Read the Letter (PDF)
“We respectfully request that you produce VA’s implementation plan that would be deployable as soon as this novel treatment option is approved for clinical use”, the letter reads.
Opinion: Ketamine bros are giving psychedelics a bad rap. That’s a problem for those who need them. (Apr 24) ↗ USA Today
Agony over ecstasy: FDA bid shows it’s hard to test psychedelics (Apr 27) ↗ The Washington Post
Psychedelic drugs to treat post-traumatic stress disorder (PTSD) (Apr 22) ↗ UK Parliamentary Office of Science and Technology
Psychedelic drugs to treat eating disorders (Apr 22) ↗ UK Parliamentary Office of Science and Technology
Two new Rapid Response briefings from the UK Parliament’s POST look at the state of the evidence for psychedelics’ use in treating PTSD and eating disorders.
Psychedelics and their therapeutic use – Linkedin Live interview with Steffen Thirstrup, EMA’s Chief Medical Officer (Tuesday, May 7) ↗ EMA
Psychedelic therapy for veterans MUST be implemented by the Biden administration says former Navy SEAL who credits drugs for saving his life after brutal combat (Apr 23) ↗ Daily Mail
How to untangle ethics of psychedelics for therapeutic care (Apr 23) ↗ The Harvard Gazette
How a psychedelic retreat helped me face up to stage four cancer (Apr 27) ↗ The Times
It Is High Time the U.K. Changes Psychedelics Laws (Apr 22) ↗ The Regulatory Review
NEW RESOURCE
Psychedelic Company Financing Tracker ↗ Psychedelic Alpha
April 15 - 21, 2024
This Week’s Feed, Sponsored by…
May 23-24, Boston
The 4th Annual Psychedelic Therapeutics & Drug Development Conference offers a unique opportunity to delve into the rapidly evolving field of psychedelic science and its potential in healthcare. Plenary talks and panel sessions will see a wide range of topics covered including drug scheduling, the future of psychedelic science, clinical trial design, research protocols, pain and psychedelics and precision medicine in mental health care.
Pα+ Psychedelic Bulletin #161: Numinus Shifts Focus to US; Algernon Makes DMT for Stroke Lead Asset; atai Pivots to IV Ibogaine (Apr 17) ↗ Psychedelic Alpha
Mushroom death mystery at wellness seminar triggers police probe (Apr 16) ↗ The AGE
Researchers Ask Federal Court To Block DEA From Banning Two Psychedelics Under ‘Unconstitutional’ Administrative Process (Apr 17) ↗ Marijuana Moment
The Unlikely Force Behind a Push to Legalize ‘Shrooms’ in New York (Apr 19) ↗ NYT
“A lobbying effort led in part by religious groups has state lawmakers considering two different measures that would legalize psilocybin, a drug known as “magic mushrooms.””
Psychedelic-Assisted Therapy Is Going Mainstream. How Will the Industry Grow Around It? (Apr 19) ↗ Kellogg Insight
GUEST WRITERS
Are you interested in writing for Psychedelic Alpha? Please reach out to hello@psychedelicalpha.com with a short blurb about yourself, topics you might be interested in writing about, and any published work samples.
New Horizons in Healing: The Psychedelic Renaissance in the Middle East (Apr 15) ↗ Newsweek
Global Perspectives on Psychedelics Regulation (Apr 15) ↗ The Regulatory Review
This six-part series will see a new article published each weekday through next Tuesday.
Business Tripping: The Professionals Trying Drugs to Get Better at Work (Apr 21) ↗ WSJ
Ayahuasca: psychedelic brew landing shamans in jail (Apr 16) ↗ France 24
Eyes wide shut: Why psychedelic trips intensify with eyes closed (Apr 18) ↗ Big Think
Michael Pollan’s long and strange trip: shifting perspectives on food and psychedelics (Apr 21) ↗ KCRW
Push to legalize psychedelic-assisted therapy treatment continues (Apr 17) ↗ CBS News
Downtown Windsor magic mushroom dispensary raided by cops for 4th time, 1 arrested (Apr 18) ↗ CBC
HAPPY BICYCLE DAY
Bicycle Day marks an unofficial commemoration of the first use of LSD (Apr 19) ↗ NPR (2 min audio)
The Bad Trip Detective (Apr 15) ↗ Nautilus
“[Jules] Evans doesn’t advocate against psychedelics. But by exposing the hazards that tripping could involve, Evans hopes to temper the prevalent ethos of breezy optimism with a dash of caution.”
Psychedelic Community Divided Over Upcoming Conference in Israel (Apr 15) ↗ Filter Mag
Psychedelic Travel Experiences Are More Popular Than Ever (Apr 17) ↗ Condé Nast Traveler
The endless quest to replace alcohol (Apr 18) ↗ Vox
“From kava to “sleepy girl mocktails,” can anything ever take the place of booze?”
Shulgin Farm Announces Seed Crystal Campaign to Preserve Psychedelic History and Build Community Hub (Apr 18) ↗ Press Release
Psychedelic treatments on cusp of approval, but questions remain (Apr 16) ↗ PharmaPhorum
April 8 - 14, 2024
April 27-28, San Francisco
Chacruna’s two-day Psychedelic Culture conference fosters conversations around topics including Indigenous Reciprocity & Decolonial Dialogues, Psychedelic Justice, Protection of Sacred Plants & Cultural Traditions, and voices from the Global South. Hosted at the Brava Theater in San Francisco, the event also includes music and meditation circles as well as rapé ceremonies.
Developing Esketamine (Spravato) and Lessons for Psychedelic Drug Developers with Jaskaran Singh (Apr 12) ↗ Psychedelic Alpha
Josh sits down with Jaskaran (‘Jaz’) Singh, Vice President Psychiatry Development at Neurocrine Biosciences. For the purposes of this conversation, however, we focus on Singh’s role in spearheading the development of esketamine for treatment-resistant depression, now marketed as Spravato.
Here, we discuss how Singh’s early work assessing ketamine’s antidepressant effects at the National Institute of Mental Health (NIMH) encouraged him to move into industry; how his team decided to pursue esketamine; lessons learned that might be relevant for psychedelic drug developers; and his broader outlook on the field.
As California Seeks to Legalize Psychedelics for Therapy, Oregon Provides Key Lessons (Apr 12) ↗ KQED
EU launches landmark €6.5M study on use of psychedelics to treat mental disorders (Apr 11) ↗ Science Business
Psychiatry drugs finally have pharma’s attention. Can they keep it? (Apr 8) ↗ Biopharma Dive
“Arguably the buzziest area of research are psychedelic compounds. Long dismissed because of thorny legal and scientific issues, psychedelics are being taken more seriously as possible treatments for anxiety, depression and psychosis.”
Seaport Therapeutics Launches with $100 Million Oversubscribed Series A Financing Round to Advance Novel Neuropsychiatric Medicines (Apr 9) ↗ Press Release
The company’s pipeline includes SPT-348, “a prodrug of a non-hallucinogenic neuroplastogen in development for the treatment of mood and other neuropsychiatric disorders, [which] leverages Glyph to create a potential first-in-class treatment with improved pharmacokinetics and tolerability compared to conventional psychedelics.”
Psychedelics Paid for by Work? It’s Coming (Apr 11) ↗ WSJ
Psychedelic drug retreat reports 183% spike in bookings as health experts cite ‘huge downside’ (Apr 13) ↗ FOX News
Can Microdosing Psychedelics Help Golfers Raise Their Game? (Apr 11) ↗ Men’s Health
Almost No One Is Happy With Legal Weed (Apr 8) ↗ The Atlantic
Jane C. Hu asks: Will legal psychedelics be any better?
Hu also appeared on Slate’s ‘TBD’ podcast on Sunday in an episode titled, Is America Ready for Legal Psychedelics?
Are Mushrooms the New Prozac? (Apr 8) ↗ Brown Alumni Magazine
What a Terror Attack in Israel Might Reveal About Psychedelics and Trauma (Apr 11) ↗ NYT
No magic at city council for Vancouver mushroom dispensaries as retail framework rejected (Apr 10) ↗ Global News
This Real Estate Mogul Is Funding Psychedelics Research to Support the LGBT+ Community (Apr 9) ↗ Inside Philanthropy
Natural Medicine Advisory Bulletin 10.1: Legislative Update (Apr 9) ↗ Psychedelic Alpha X Vicente LLP
The big business bet on psychedelic drugs (Audio, 20 mins) (Apr 7) ↗ The Globe and Mail
April 1 - 7, 2024
This Week’s Feed, Sponsored by
Clerkenwell Health is building the infrastructure for developing and delivering mental health and CNS treatments through their network of hybrid research and care clinics, CRO services and therapist training programme. Based in Central London, Clerkenwell Health offers the only purpose-built commercial clinical research site in Europe dedicated to psychedelic-assisted therapies.
ANALYSIS
MindMed’s ‘Total Elimination’ of Psychotherapy in LSD Study Stokes Debate Around Its Role in Psychedelic Therapies (Apr 5) ↗ Psychedelic Alpha
In March, MindMed scored an FDA Breakthrough Therapy Designation for its LSD-D-tartrate candidate (MM120) for generalised anxiety disorder (GAD). In this piece, Josh takes a closer look at the company’s claim to have ‘eliminated’ psychotherapy from its Phase 2b study of MM120 and explores how a broader ‘Spravato-isation’ of psychedelic therapies is stoking debate around the contribution of psychotherapy (or lack thereof) in these interventions.
Magic mushrooms should be available on NHS, says Labour MP (Apr 5) ↗ The Telegraph
“Charlotte Nichols, who has PTSD, says there is enough evidence to prescribe psilocybin therapy as mental health treatment”
Natural Medicine Advisory Bulletin 10: March 2024 (Apr 4) ↗ Psychedelic Alpha X Vicente LLP
Vicente LLP reviews the March 15th Colorado Natural Medicine Advisory Board meeting, where draft rules for Facilitator licensing and training were discussed.
INTERVIEW
Senator Kirk Cullimore on Utah’s MDMA and Psilocybin Pilot Program (Apr 3) ↗ Psychedelic Alpha
SPECIAL EDITION
April 1st Edition of the Psychedelic News Feed (Apr 1) ↗ Psychedelic Alpha
Owing to some bizarre headlines from across the psychedelics space, we have compiled a special edition of our Psychedelic News Feed.
I tried psychedelic drugs to treat my depression. Here’s what happened (Apr 7) ↗ The Times
LSD, Ecstasy, magic mushrooms coming to a clinic near you? Legalization nears for psychedelics (Apr 5) ↗ The Globe and Mail
Why Psychedelic Therapy Needs Specially Trained Therapists (Apr 2) ↗ Psychology Today
FEATURED PSYCHEDELIC JOBS
- Senior Researcher at Arcadia Medicine
- Postdoc Research Fellow working on psychedelics for SUDs, among other things, at Brigham and Women’s Hospital
- People Operations Manager at Lykos Therapeutics
Explore more roles and join our Talent Network: ↗ Psychedelic Alpha Job Board
She had a severe brain injury—so her husband turned to an unprecedented therapy (Apr 2) ↗ National Geographic
Hot air balloon pilot had high level of ketamine in his system during crash that killed 4, toxicology report finds (Apr 4) ↗ CNN
FREE EVENT
April 12: The Therapeutic Use of Psychedelic Drugs: Legal, Policy and Neuroscientific Perspectives Symposium ↗ American University
Read more about the symposium, at which our Editor-at-Large Graham Pechenik will be speaking, via this American University article. Free registration is available.
March 25 - 31, 2024
Pα+ PSYCHEDELIC BULLETIN
Pα+ Psychedelic Bulletin #160: Mutual Recognition for MDMA-AT in the UK? Beckley Shares Cut of 5-MeO-DMT Data; and more (Mar 29) ↗ Psychedelic Alpha
Pα+ NEWS / ANALYSIS
ICER Draft Evidence Report on Lykos’ MDMA-Assisted Psychotherapy Deems Clinical Evidence “Insufficient” (Mar 27) ↗ Psychedelic Alpha
We review ICER’s draft evidence report on Lykos Therapeutics’ MDMA-AP, which finds that the publicly-available clinical evidence on the intervention is “insufficient” to inform a comparative clinical effectiveness analysis. The report also highlights clinical and ethical concerns surrounding the studies.
HPPD, the drug-induced disorder which can be brought on by psychedelic substances (Mar 29) ↗ ABC News
Compass Pathways Board Chair and Co-Founder George Goldsmith and Co-Founder Ekaterina Malievskaia Step Down from Board of Directors (Mar 28) ↗ Press Release
Special Issue on Psychedelic Therapy: A Primer for Primary Care Clinicians (Mar/Apr) ↗ American Journal of Therapeutics
atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression (Mar 27) ↗ Press Release
According to the press release, a single dose of BPL-003 “demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12”.
It’s worth noting that the initial topline results represent 12 participants.
Beckley Psytech also published its own press release.
Promise, apprehension during State House hearing on psychedelics (Mar 27) ↗ Boston Globe
LSD, Ecstasy Lure Traders Betting on ‘Psychedelic Renaissance’ (Mar 28) ↗ Bloomberg
Can psychedelics with shorter yet intense experiences cure people with alcohol dependence? (Mar 27) ↗ Outsourcing Pharma
Psychedelics Design Conference (April 11, Virtual) ↗ Psychedelics Design
Tickets are priced at £20 / $25. Get 15% off, using code PsychedelicAlphaPD15 here.
No hallucination: Hundreds back magic mushrooms at Oakland psychedelic wellness conference (Mar 30) ↗ SF Chronicle
Jonathan Haidt on Religion, Psychedelics and the Anxious Generation (Mar 27) ↗ Theos
For a Firefighter Struggling With Trauma, Ketamine Therapy Offers Hope (Mar 26) ↗ NYT
For Brilliant Color: Packaging the First LSD Blotter (Mar 25) ↗ MIT Press
Many users of Oregon’s legal psilocybin program aren’t Oregonians at all (Mar 26) ↗ Oregon Live
Why are so many young people taking hallucinogens? (Mar 27) ↗ Dazed
Six Months After Opening, a Northeast Portland Shroom Center Becomes the First to Close (Mar 27) ↗ Willamette Week
Naropa University Launches Pioneering Psychedelic Minor (Mar 29) ↗ Press Release
March 18 - 24, 2024
This week’s feed is sponsored by
April 18-19, San Francisco
Discovery Sessions brings together thought leaders at the forefront of psychedelics across culture, policy, science, and conscious entrepreneurship to engage in a spirited, inclusive dialogue to envision a brighter future.
PSYCHEDELIC BULLETIN
Pα+ Psychedelic Bulletin #159: Patient Access to MDMA-Assisted Therapy; Notes from SXSW; Whole Mushroom vs. Synthetic Psilocybin (Mar 21) ↗ Psychedelic Alpha
Usona Institute Announces Launch of uAspire Phase 3 Clinical Trial Investigating Psilocybin for Major Depressive Disorder (Mar 20) ↗ Press Release
Visit ClinicalTrials.gov for more information on the protocol (NCT06308653).
Fluence’s Elizabeth Nielson on Professional Education for the Psychedelics Field (Mar 19) ↗ Psychedelic Alpha
A Psychedelics Reporter With a Changing Perspective (Mar 20) ↗ NYT
Magic and Medicinal: On the Pharmacological Potential of Mushrooms (Mar 20) ↗ Literary Hub
An excerpt from Molds, Mushrooms, and Medicines: Our Lifelong Relationship with Fungi by Nicholas P. Money.
Notes from the International Society for Research on Psychedelics’ 2024 Conference in New Orleans (Guest Contribution) (Mar 20) ↗ Psychedelic Alpha
Treat addiction with psychedelics? (Mar 22) ↗ The Harvard Gazette
Cops Demand the Right for Cops to Do Psychedelic Drugs (Mar 23) ↗ Daily Beast
VA Portland Health Care opens first-of-its-kind psychedelic medicine research center (Mar 19) ↗ Portland Business Journal
What psychedelics legalisation and decriminalisation looks like around the world (Mar 21) ↗ BBC
Through the Psychedelic Looking Glass (Mar 18) ↗ New Lines
Webinar: Breaking Down the First Draft Rules for Psychedelics in Colorado (Mar 19) ↗ reMind via LinkedIn
The psychedelic AI found (Mar 18) ↗ POLITICO
POLITICO covers Mindstate Design Labs’ IND submission for a Phase I study of 5-MeO-MiPT.
Ibogaine, the psychedelic, unlikely to receive approval as opioid treatment, says top addiction researcher (Mar 21) ↗ STAT
“The remarks from Nora Volkow, the longtime director of the National Institute on Drug Abuse, serve as a cautionary note amid widespread enthusiasm about ibogaine, a naturally occurring substance that drug companies and researchers have increasingly cast as a potential paradigm-shifting addiction treatment.”
The rise of the work drug (Mar 24) ↗ Business Insider
The Psychedelic Evangelist (Mar 21) ↗ NYT
“Get on Your Knees”—Alberta Cops Raid Home Over Ayahuasca Delivery (Mar 20) ↗ Filter
What a long, strange trip it’s been for this psychedelic library book returned 13,437 days late (Mar 19) ↗ Denver Post
March 11 - 17, 2024
NEWS / ANALYSIS
Gilgamesh Scoops $14m from NIDA to Develop Safer Ibogaine Analog for Opioid Use Disorder (Mar 14) ↗ Psychedelic Alpha
NEWS / ANALYSIS
Cybin Scores Breakthrough Therapy Designation for Deuterated Psilocybin Analog in MDD, Shares 4-Month Data (Mar 13) ↗ Psychedelic Alpha
How Psychedelic Drugs Are Going Mainstream (Mar 17) ↗ Mother Jones
Kentucky should reconsider using psychedelics to treat opioid addiction, attorney general says (Mar 13) ↗ Associated Press
Ayahuasca-Using Church’s Tax Status Claim Faces Skeptical Court (Mar 11) ↗ Bloomberg
Sorry, You Probably Cannot Get MDMA Through Telehealth (Mar 12) ↗ Bill of Health
Cybin Initiates Phase 2 Proof-of-Concept Study of CYB004 in Generalized Anxiety Disorder (Mar 15) ↗ Press Release
VA-funded psychedelic therapy trials for PTSD could save lives, veteran organization says (Mar 14) ↗ FOX13
Psychedelics are about to become a casualty of Oregon’s opioid crisis (Mar 16) ↗ Vox
What Does 2024 Have in Store for Psychedelic Science? (Mar 14) ↗ Technology Networks
EXPLORE THE MAP
U.S. Psychedelic Legalization & Decriminalization Tracker (Updated March 14th) ↗ Psychedelic Alpha
We have been tracking psychedelic policy reform across the United States for a number of years now. Visit the updated map today to see the latest in your state.
A Small University Goes Big on Psychedelic Therapy Training (Mar 12) ↗ Inside Higher Ed
Ketamine’s unlikely conversion from rave drug to mental health therapy (Mar 11) ↗ New Scientist
New Scientist also produced a video on the topic (15 mins).
Denver first responders to get psychedelic crisis training (Mar 13) ↗ The Denver Post
A Psychedelic-Assisted Therapy Learning Framework – Open Source Learning Objectives for Practitioners ↗ Beckley Academy
Psychedelic drug ibogaine hailed as healing. U.S. patients ask why it’s illegal. (Mar 14) ↗ Washington Post
Could a psychedelic help solve Ohio’s opioid crisis? Ohio Treasurer just hired one of its biggest backers (Mar 11) ↗ Cleveland.com
Experts want Ecstasy and shrooms legalized. Government officials are behind the curve. (Mar 12) ↗ Houston Chronicle
From LSD to healing minds: Where are we standing in psychedelic drug development? (Mar 13) ↗ Labiotech
After crunching 70k ‘trip reports’, Mindstate looks to test first AI-derived psychedelic on humans (Mar 13) ↗ Fierce Biotech
Mindstate has submitted an IND to the FDA to study 5-MeO-MiPT, aka moxy, co-administered with an approved generic. The Phase I trial aims to dose five cohorts of ten healthy volunteers.
Magic Mushrooms Are Risky New Tool Touted by Executive Coaches (Mar 11) ↗ Bloomberg
Inc. also covered the story: Business Tripping: Tune In, Turn On, Drop $3.5K for a Psychedelic Weekend (Mar 12) ↗ Inc.
NSW Mental Health Minister Rose Jackson acknowledges calls for NSW to expand psilocybin, MDMA treatments (Mar 13) ↗ The West Australian
Elsewhere in Oz, Ex-Abbott minister hits out at ‘ridiculous MDMA ban’ (Mar 12) ↗ The West Australian
Congress wants the Veterans Affairs Department to lead the way in psychedelics research. (Mar 13) ↗ POLITICO
MAPS Provides Psychedelic Crisis Assessment and Intervention Training to Denver’s First Responders (Mar 11) ↗ Press Release
It’s time for California to take a more pragmatic approach to psychedelic drug policy | Opinion (Mar 14) ↗ The Sacramento Bee
Why conservative Missouri lawmakers want to legalize ‘magic mushrooms’ for veterans (Mar 14) ↗ Springfield News-Leader
Psychedelics and Mental Health: Rose Cartwright meets Ashleigh Murphy-Beiner (Mar 12) ↗ BBC Radio 4
Groundbreaking research into psychedelic therapy (Mar 15) ↗ Uppsala University
VA has $20 million for MDMA therapies, but that’s not all it needs (Mar 15) ↗ Task & Purpose
The Prophet Of Shroom (Mar 17) ↗ Forbes
March 4 - 10, 2024
NEWS / ANALYSIS
FDA Hands MindMed’s LSD Candidate Breakthrough Therapy Designation in Generalised Anxiety Disorder; Company Provides 12-Week Data and Fleshes Out Phase 3 Program Plans (Mar 8) ↗ Psychedelic Alpha
Psychedelic drug developer MindMed has announced that the FDA has granted breakthrough therapy designation to its LSD-D-tartrate candidate (MM120) for the treatment of generalised anxiety disorder (GAD). The company also shared topline 12-week data from the same program, as well as results of a pharmacokinetic bridging study and further details on phase 3 study design.
Pα+ subscribers can read our coverage here.
PSYCHEDELIC BULLETIN
Pα+ Psychedelic Bulletin #158 (Mar 6) ↗ Psychedelic Alpha
- Fluence and UPRA Team Up to Bring Psychedelic Therapy Training to Ukraine
- MindBio’s Small Open Label Microdosing Study Shows Promise in MDD
- Biomind’s 5-MeO-DMT Study Shows Promise, But Small Sample and Unclear Protocol Temper Excitement
- Oregon Psilocybin Services Complaints
- Further Reading & Other Stories
Psychedelic news: The government finally fast-tracked LSD as an anxiety treatment (Mar 7) ↗ Fast Company
Colorado issues draft rules for psychedelic industry’s healing centers (Mar 7) ↗ Axios
How Psychedelics Could Help Soldiers Overcome Trauma (Mar 10) ↗ TIME
Powerful Psychedelic Gains Renewed Attention as a Treatment for Opioid Addiction (Mar 5) ↗ New York Times
NEWS / ANALYSIS
Prominent At-Home Ketamine Co. Founder, Juan Pablo Cappello, Sounds Alarm, Withdraws Support for the Practice (Mar 4) ↗ Psychedelic Alpha
One of the at-home ketamine industry’s biggest boosters has turned bearish, calling for caution among patients and providers and withdrawing his endorsement of the practice. Here, we take a closer look at the case study that changed Cappello’s mind as well as broader concerns around at-home ketamine operators, and we speak with Cappello himself.
atai Life Sciences Announces First Participant Dosed in Phase 1b Trial of VLS-01 (Mar 4) ↗ Press Release
Readers might remember that atai shared topline results from a Phase 1 study of the candidate back in October 2023, finding the oral transmucosal film (OTF) formulation to be “well-tolerated with a favorable safety profile”. However, the company announced it would “further optimize” the candidate in preparation for a Phase 2 study in treatment-resistant depression.
As such, this Phase 1b study will compare an improved OTF formulation of the candidate with IV. The improvements include taste masking, a backing layer, “and enhancements to further increase permeability.”
For reference, atai dosed the very first subject with VLS-01 in Q4 2022.
Vancouver to reinstate business licence of illegal magic mushroom dispensary (Mar 5) ↗ Vancouver Sun
“At a business licence hearing Tuesday, a three-person panel approved a motion asking staff to reinstate the licence with terms that clarify the business is involved in education and advocacy of medicinal psychoactive substances.”
“We opened the door now, just a crack, but it’s only going to get bigger”, said Dana Larsen.
On March 7th, Vancouver Sun columnist Dan Fumano wrote a piece titled, “Dan Fumano: Psychedelics are illegal — and Vancouver police say criminal charges could be coming”.
China’s emerging psychedelic scene looks a lot like Silicon Valley (Mar 6) ↗ Vox
Ego tripping: Why do psychedelics “enlighten” some people — and make others giant narcissists? (Mar 8) ↗ Salon
INTERVIEW
Bay Staters for Natural Medicine Co-Founder, James Davis, on Grassroots Psychedelic Policy Reform, a Community-based Facilitator Network, and the Corporatisation of Psychedelics (Mar 8) ↗ Psychedelic Alpha
Psychedelics, Solid Tumors Will Be Key Focuses for Investors in 2024 (Mar 6) ↗ BioSpace
Marketing magic: How influencers are helping sell psychedelics to social media masses (Mar 4) ↗ The Denver Post
Hidden trauma: Do psychedelics reveal memories or create fake ones? (Mar 4) ↗ Big Think
Psychedelic Lobbying and Regulatory Capture (Mar 4) ↗ Bill of Health
CALL FOR SURVEY PARTICIPANTS
Do you have experience conducting psychedelic-assisted therapy outside of the research setting? You may be eligible to participate in a new study from Imperial College London’s Centre for Psychedelic Research. Learn more and participate.
Leading psychedelic trainer Ben Sessa suspended over relationship with vulnerable former patient (Mar 6) ↗ ABC News
Cleveland Clinic Expands Psychedelic Research and Launches First Psilocybin Trial in Northeast Ohio (Mar 6) ↗ Cleveland Clinic
Bringing Neuroplastogens to the Window: Q&A With Delix CEO Mark Rus (Mar 5) ↗ Pharma Executive
Who will staff the psychedelic resurgence? (Mar 7) ↗ Open Access Government
Were Plato and Dante munching on magic mushrooms? Probably (Mar 8) ↗ The Standard
