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December 11 – 17, 2023

Pα+ Psychedelic Bulletin #151: Psilocybin for BDII, ACNP Readouts, Methylone for PTSD, and More Psychedelic Drug Dev. News

Psychedelic Alpha ↗

Featured content in this Issue:

  • MAPS PBC Files New Drug Application for MDMA-Assisted Therapy for PTSD
  • Compass-Sponsored Study of Psilocybin in Bipolar Type II Finds Preliminary Safety and Efficacy, Potentially Warranting Larger Trial
  • MindMed Shares Topline Results from LSD for Generalised Anxiety Disorder Study
  • Clairvoyant Therapeutics Provides Update on Ph 2b Psilocybin for Alcohol Use Disorder Trial
  • Delix Provides A First Look at DLX-001 Phase I Data
  • Intra-Cellular Therapies Presents Preclinical Data from Non-Hallucinogenic Psychedelics Program
  • Gilgamesh Wraps Phase I Trial of GM-2505
  • Cybin Provides Further CYB003 Data
  • Transcend Provides First Look at Phase 2 Methylone for PTSD Data

Read Bulletin 151 now.

MAPS Public Benefit Corporation (MAPS PBC) has filed a New Drug Application (NDA) with FDA for MDMA-Assisted Therapy for PTSD.

Psychedelic Alpha ↗

MAPS Public Benefit Corporation (PBC) has submitted its New Drug Application (NDA) to the FDA in order to seek marketing approval of MDMA-assisted therapy (MDMA-AT) for PTSD.

The organisation and its parent non-profit, MAPS, has been conducting clinical studies of MDMA-AT for over twenty years, making this a significant milestone.

And it’s not just a milestone for MAPS: this is the first psychedelic-assisted therapy submitted to the FDA for approval.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD,” said MAPS PBC’s CEO, Amy Emerson.

“If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health”, she continued.

More Coverage:

  • FDA to review MDMA-assisted therapy, a milestone for psychedelics (WaPo)
  • The US Is One Step Closer To MDMA Therapy (VICE)
  • FDA may review MDMA for the treatment of PTSD (CNN Health)
  • First-ever drug application for MDMA finally reaches FDA after near 40-year journey (Fierce Biotech)
  • FDA to consider psychedelic-assisted therapy for PTSD (The Hill)

DEA Again Moves to Place DOI and DOC in Schedule I of the Controlled Substances Act

Federal Register ↗

The agency withdrew its earlier effort to do so in August 2022, but noted it would be back with an amended procedure.

“Perhaps this withdrawal is the product of a procedural quirk as opposed to a change in attitude from the agency”, we wrote in Bulletin 116 back in August 2022.

It certainly seems so.

Comments close on January 12th, 2024.

One has to wonder whether proposing this rule over the holidays might reduce the likelihood of significant public and industry engagement, as seen in DEA’s first attempt to schedule these substances.

Comments may be submitted here.

In Memoriam: Roland R. Griffiths, Ph.D

Neuropsychopharmacology ↗

“Griffiths lived a remarkable and consequential life. As one young physician scientist said upon hearing of his death: he changed the world for the better.”

Reminder: Don’t Put Your Medical License At Risk

On Drugs ↗

“Bottom line: if you are a medical professional flirting with these new systems, be careful. Certainly, dial down blasé echoing from the purveyors of the medical marijuana establishment. Get a robust and unbiased legal opinion. Don’t let someone shoot from the hip.”

AWESTRUCK

Johns Hopkins Magazines ↗

“The scientists plan to spend another year or so slipping the VR headset on patients dosed with psilocybin to learn what settings might dial up the awe of a psychedelic experience.”

December 4 – 10, 2023

Ex-Alaska Airlines pilot accused of trying to cut plane’s engines indicted on endangerment charges

Associated Press ↗

Attempted murder charges against a former pilot have been dropped. Instead, he now faces 83 reckless endangerment charges.

The off-duty pilot had consumed psilocybin mushrooms around 48 hours prior to attempting to cut the engines off during an Alaska Airlines flight.

“The attempted murder charges were never appropriate in this case because Captain Emerson never intended to hurt another person or put anyone at risk – he just wanted to return home to his wife and children,” his defense lawyers Ethan Levi, Noah Horst and Norah Van Dusen said in a statement. “Simply put: Captain Emerson thought he was in a dream.”

EVENT RECAP

reMind’s Psychedelics Business Forum

↗

We had a great time in Las Vegas at reMind’s second Psychedelics Business Forum, which brought together a diverse crowd to discuss the present and future of the psychedelics industry.

I (Josh) really enjoyed the focus on sharing practical tips for operators and the focus on what entrepreneurs and practitioners can do right now, or in the near future. This was a nice change from my usual beat, which is often focused on things like drug development that have long timelines.

It was great to moderate a couple of panels, too. I spoke with Courtney Barnes and Sam Chapman about psychedelic policy reforms, as well as Nykol Bailey Rice and Chris Walden about ketamine clinics. Having written quite a bit about both of these topics over the past few years, it was refreshing to hear from those with intimate, first-hand experience.
Josh Hardman

Having attented many psychedelic conferences in the past few years, I appreciated reMind’s focus on making plenty of space for networking in the program. Providing this scaffolding and drop-in networking space was especially helpful for people like me who simultaenously suffer from networking FOMO and networking burnout at conferences.

Josh Court Sam

Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes

JAMA ↗

This Compass Pathways-funded study evaluated a single dose of psilocybin with psychotherapy in 15 individuals with bipolar II depression.

“…most participants met remission criteria on the Montgomery-Åsberg Depression Rating Scale 3 weeks after a single 25-mg psilocybin dose, and most remained in remission 12 weeks postdose with no increase in mania/hypomania symptoms or suicidality.”

“The findings suggest efficacy and safety of psilocybin in bipolar II depression and support further study of psychedelics in this population.”

November 27 – December 3, 2023

Psychedelic Bulletin #150: Drug Development and Research Updates

Pα+ Psychedelic Bulletin #150: Drug Development and Research Updates

Psychedelic Alpha ↗

This Issue of the Bulletin primarily focuses on psychedelic drug development and business stories, with around 4,000 words of coverage and analysis.

Featured content in this Issue:

  • GH Research’s Lead 5-MeO-DMT Candidate Faces Development Hiccup, Potential Hold-Up
  • Psychae Therapeutics Scores AUD $4.5m to Develop DMT-Based Candidate
  • Cybin Closes $30m Offering
  • Brain & Behavior Research Foundation Awards Grants to 8 ‘Young Investigators’ Exploring Psychedelics
  • atai Buys Out Remainder of DemeRx’s Ibogaine Asset; Announces Novel 5-HT2A Agonist Candidates
  • Compass Pathways Commences UK Portion of Phase 3 Trial, Officially Opens Centre for Mental Health Research and Innovation in London
  • Awakn Plans to Commence Enrollment for Phase 3 Study of Ketamine for Severe Alcohol Use Disorder in Q1 2024

Read Bulletin 150.

UPCOMING EVENTS

↗

reMind Psychedelics Business Forum
28-29 November, Las Vegas, U.S. (info & tickets). Use Josh’s code for 20% off: REMJHARDMAN20.

Horizons NW
1-3 December, Portland, U.S. (info & tickets). Use PALPHA-NW-15 for 15% off.

Psychedelics and mental health (Seminar)
7 December, Imperial College London (Zoom registration)

Rapid-Acting Mental Health Treatment Summit
7 Jan, 2024, San Francisco, U.S. (info & tickets).

Leave No Drug Behind

Transform ↗

“Psychedelic drugs (or any drug), should not be treated as exceptional and more viable for decriminalisation or legal regulation simply because they are perceived to present lower risks than other drugs, be therapeutically more useful, or be somehow more spiritually significant.”

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