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November 20 – 26, 2023

Pα+ Psychedelic Patent Analysis (October 2023)

Psychedelic Alpha ↗

Our monthly Psychedelic Patent Analysis provides headline figures regarding published psychedelic patent applications and grants, before diving into commentary on a select handful of patent-related actions.

This month:

  • MindMed Scores Psilocybin-Antidepressant Co-Treatment Patent
  • A Spate of PCTs Published from GH Research
  • Early Fruits of Cybin’s Small Pharma Acquisition

Note: the monthly Psychedelic Patent Analysis is a Pα+ subscriber benefit (join today). Given that this is a new format, we’re making this first issue available without a paywall.

Podcast: The Psychedelic Industry with Josh Hardman

Drug Science ↗

“In this episode, Josh Hardman, the founder of Psychedelic Alpha, explores the multitude of challenges currently being encountered by the psychedelic industry. He engages in discussions regarding the progress of decriminalisation and legalisation initiatives, upcoming clinical trial milestones, and delves into the current state and the potential evolution of the Psychedelic industry.”
Drug Science Josh Thumbnail

Plea for psychedelic rules reform

RACGP ↗

“A new coalition of healthcare professionals wants a review of ‘overly restrictive’ [psychedelics] prescribing guidelines, but a GP expert says changes must be done ‘slowly and carefully’.”

November 13 – 19, 2023

WEEKLY POLL

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You answered:

  • None: 37%
  • 1: 30%
  • 2: 26%
  • 3: 5%
  • More than 3: 2%

Psychedelic Bulletin #149: Worldwide Psychedelic Policy Developments

Pα+ Psychedelic Bulletin #149: Worldwide Psychedelic Policy Developments

Psychedelic Alpha ↗

This Issue of the Bulletin focuses on various policy-related developments that have materialised in the past few weeks. These include inaugural hearings in the U.S. House, subcommittee meetings and forums, as well as the publication of reports and key changes to major psychedelic policy reform efforts.

In this Issue:

  • TREAT Retreats
  • Wiener Regroups: Decrim. Off the Agenda
  • California Psilocybin Decrim. Initiative Continues Gathering Signatures
  • Veterans’ Affairs Subcommittee on Health Discusses Psychedelics
  • Canadian Senate’s Subcommittee on Veterans Affairs: “The Time is Now” to Fund Psychedelic-Assisted Therapy Research
  • Transform Publishes a “Practical Guide” to Regulating Psychedelics
  • UK Government Responds to Drugs Committee’s Report
  • More Policy News

Read the 5,000+ word Issue.

Colorado Natural Medicine Advisory Bulletin #5: October 2023

Psychedelic Alpha ↗

While some aspects of the Natural Medicine program, like cultivation and testing requirements, are more or less settled, the Board is still wrestling with some difficult questions.

The Board is attempting to strike a delicate balance between regulatory safety and program sustainability, a task that may turn out to be the most difficult one of all.

Read the latest via our Bulletin, written by Jeff Fitzgerald and Vicente LLP.

VA “committed” to studying psychedelics for PTSD

Axios ↗

“Based on our assessment of the literature to date, there is still much to learn, and much yet to be understood, about the potential benefits of psychedelic compounds. Our department is not only focused on finding the best innovative treatments and cures but doing so safely.” – VA assistant undersecretary for health, Carolyn Clancy

Regarding MAPS’ Phase 3 program, Clancy suggested the VA’s main concerns are related to a relatively small sample size and even smaller number of veterans included.

Library: Psychedelic REMS

Pα+ Library: Psychedelic REMS

Psychedelic Alpha ↗

Here, we sketch out what a psychedelic Risk Evaluation and Mitigation Strategy (REMS) might look like, which should go some way to highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.

How to Regulate Psychedelics

Transform Drug Policy Foundation ↗

Transform’s Practical Guide is now available to download. Consider ordering a hard copy to support their work.

Magic mushrooms and the mind

The Week ↗

“A growing number of states and cities are legalizing the use of psychedelic fungi in therapy. Some experts think that’s a big risk.”

November 6 – 12, 2023

WEEKLY POLL RESULTS

↗

We Asked: In 2033, this molecule will have approvals for the most indications in the U.S.:

You answered:

  • MDMA (48%)
  • Psilocybin (44%)
  • LSD (4%)
  • DMT (0%)
  • Other (4%

Cybin Announces up to US$64 Million Offering of Units

Press Release ↗

The company announces “a firm commitment underwritten offering” of around 67 million units at a price $0.45 per unit for gross proceeds of $30m. Up to an additional $34m could be raised if warrants (priced at $0.51) are exercised.

Psychedelics Will Help America’s Mental Health Crisis — If the FDA Lets Them

American Institute for Economic Research ↗

The AIER, a ‘conservative and libertarian free-market think tank’ published a short article on psychedelics for mental health illness.

The bent of the article is that “it’s time for the FDA to decide” whether to ‘generate an approval process for psychedelics.” But this seems to hinge on a misunderstanding of FDA’s draft guidance on clinical investigations involving psychedelics which does not seek to establish a separate approval pathway for psychedelics.

Why We Need to Regulate Psychedelics

Transform ↗

“This is an edited extract from Transform’s How to Regulate Psychedelics: A Practical Guide – by Steve Rolles and Ester Kincová – now available to buy in print. This will be published on Nov 14th! Register for the launch webinar here.”

October 30 – Nov 5, 2023

Psychedelic Bulletin #148 (Pα+)

Psychedelic Alpha ↗

This is the first issue of our Psychedelic Bulletin that’s exclusively for Pα+ subscribers. Head to our Join page to learn more.

This issue’s contents:

  • Notes from the Conference Call: Cybin’s Deuterated Psilocybin Analog Results
  • Federal Appeals Court Throws Lifeline to Psilocybin Rescheduling Effort
  • UK Report on Barriers to Research with Controlled Drugs Expected to Publish Soon
  • Meta Ignores its Oversight Board’s Suggestions Regarding Ketamine Ads
  • ‘Mushroom Pilot’ Case Sparks Soul-Searching
  • Leading UK Psychedelic Drug Policy Reform Group Rebrands, Founder Mired by Arrest
  • NIH to Establish and Fund a National Cannabis Research Centre
  • New NIDA Grant Opportunity for Psychedelics
  • Ethics Approval for Study of Psychedelics in Romantic Relationships
  • Other Headlines & Weekend Reads

Cybin Announces Unprecedented Positive Phase 2 Interim Data for CYB003 in Major Depressive Disorder Meeting Primary Efficacy Endpoint with Rapid and Significant Improvements in Depression Symptoms After Single Dose

Press Release ↗

Pα Take: It’s worth stressing once again that this is a small N study, and today’s interim data reflects a subset of that already-small N. Nonetheless, the data appear positive, with a substantial mean MADRS score reduction and safety profile that gives other psychedelic candidates a real run for their money. It now remains to be seen whether these results are reflected in the full Phase 2a data and ultimately sustained in a larger Phase 3 program. With plans to commence a Phase 3 program as early as Q1 2024, along with a Phase 2 study of its CYB004 deuterated DMT candidate for generalised anxiety disorder, it’s going to be a busy couple of quarters for Cybin staff and investigators! ∎  ↗ Psychedelic Alpha

Photo shows vehicle crashed into ‘Shroomyz’ shop in Toronto… again

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There’s little information about the Friday morning incident: chiefly, whether it’s an accidental car crash or intentional ram-raid (or a pure act of malice, etc.).

Remember that, because they’re operating outside of the law, stores like Shroomyz are often relying on cash for transactions.

The neighbouring store, which has been forced to close, wrote on Instagram that “someone drove their truck into [Shroomyz…] for what I’m sure are some pretty nefarious reasons.”

The striking image was posted by u/Key-Suggestion-1377 on the Toronto subreddit, and is now reported in a number of local outlets.

It’s not the first time this has happened. Back in September, a car was crashed into another Shroomyz store on Dunlop Street West just after midnight on a Wednesday.

Based on images, the crash wasn’t quite as destructive as yesterday’s RAM truck.

WEEKLY POLL RESULTS

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We Asked: Do you consider ketamine a psychedelic?

You answered:

  • Yes (43%)
  • No (36%)
  • Not sure (21%)

Psychedelic Summer School! (UvA, June 2024)

UvA Summer School ↗

Christian Greer and Erik Davis are running a two-week summer school intensive at University of Amsterdam next year. The Psychedelic Universe: Global Perspectives on Higher Consciousness will provide “an in-depth exploration of psychedelic consciousness across space, time, and culture”.

Vancouver police bust three storefronts selling psilocybin and psychedelics

Vancouver Sun ↗

“Longtime pot activist Dana Larsen opened the stores on East Hastings, West Broadway and Granville street starting in 2019”

“Larsen claims his operations are “under attack by the city,” and is urging supporters to attend a public hearing about the business licences on Dec. 6 at city hall.”

Over in California, Bakersfield man arrested in illegal marijuana dispensary bust on California Avenue: BPD (Oct 31) ↗ Bakersfield Now

SCHOLARSHIPS

Usona Institute ↗

Usona Institute’s scholarship program supports practitioners seeking training or certification in psychedelic-assisted therapy and emerging scholars engaged in post-graduate degree programs focusing on psychedelics.

Breakthrough antidepressants with fewer side effects could help millions of Americans. Here’s what the future of treatment may look like

Fortune ↗

“Products in the works at various pharmaceutical companies aim to make ketamine and other dissociative drugs, such as psychedelics like MDMA, even better antidepressants. Some drugs combine ketamine with other medicines to extend its efficacy and reduce the need for such frequent doctor visits. Other research explores ways to cut the hallucinogenic effects from ketamine and psychedelics while holding onto the antidepressant effects.”

TREAT California Withdraws 2024 Ballot Initiative Efforts

Statement (PDF) ↗

TREAT California, which had hoped to make its way onto the state’s 2024 ballot and ultimately convince voters to endorse a $5bn psychedelic R&D institute, has withdrawn the project.

In a statement, the organisation said that while voters “have expressed widespread support for the initiative’s objectives”, polling “indicates they do not yet believe in creating a state agency to fund the program.”

Polling conducted by FM3 Research revealed striking political cleavages (which we discussed in Bulletin 147), with the average Californian independent or Republican opposing the measure.

The group announced a newly-formed nonprofit, TREAT Humanity.

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