The U.S. Drug Enforcement Administration (DEA) has proposed a major increase in quotas that govern the production and supply of psilocybin for research purposes. The proposed adjustments—which would represent a 50x increase in the quota for psilocybin, for example—would likely reduce friction around the acquisition of such substances for both nonclinical and clinical research.
Elsewhere, Field Trip launches a ketamine-assisted therapy co-operative program, MindMed publishes an international patent application with BioXcel (which covers technology that isn’t inherently psychedelics-related), and more…
Psychedelic Sector News
Field Trip Launches Ketamine-Assisted Therapy Co-Operative Program
Earlier this week, Toronto-based Field Trip Health announced the launch of ‘KAP Co-op,” a program that allows independent psychedelic therapists to provide ketamine-assisted psychotherapy (KAP) at its health centers. The company will also provide KAP training programs to interested and qualified mental health professionals.
“Co-op Therapists,” once approved, will be able to access Field Trip’s network of centers and resources in order to provide KAP to their private practice clients, according to the release. Clients, meanwhile, will be able to access the company’s medical teams for screening, prescribing, and dispensation of ketamine. All preparation and integration therapy, meanwhile, will continue to be delivered by their existing therapist.
Field Trip will charge an introductory price of $400 to screen KAP Co-op clients and dispense ketamine at one of its health centers. In the future, Field Trip hopes to roll out other psychedelic-assisted therapies through this channel.
This is a somewhat decentralised business model, in which the bulk of the therapy work, and thus cost, is provided in the context of an existing, private therapist-client relationship.
- Filament Health files 20th patent application;
- Mindcure announces 2021 financial results;
- MindMed and BioXcel publish international patent application;
- Mindset Pharma announces novel 5-MeO-DMT analogs preclinical results;
- Red Light Holland terminates merger with Creso Pharma; closes acquisition of Mera Life Sciences and published quarterly financials; completes sale and import of psilocybe truffles to Canada;
- Wesana Health: Rachel Yehuda joins Scientific Advisory Board.
DEA Proposes Significant Increase in Production Quota for Research Psilocybin
The U.S. Drug Enforcement Administration (DEA) has proposed a major increase to limits on the production of psilocybin, psilocin and marijuana used for research purposes.
The proposed adjustments, published in the Federal Register yesterday, outline the rationale and changes in quotas. While a number of other Schedule I and II substances are seeing quota changes, including a number of fentanyl-related substances that are now given modest quotas, the most significant proposed quota revisions concern psilocybin, psilocin and marijuana.
At present, the federal quota for psilocybin is set at 30g. Here, the DEA is proposing a change of that quota to 1,500g (1.5kg), a fifty-fold increase. The quota for psilocin (see our psychedelics glossary), meanwhile, is set to shift from 50 grams to 1,000g (1kg).
To understand the implications of these proposed quota increases, let’s think about this in terms of doses. Most trials of psilocybin for depressive disorders employ a 25mg dose, including Usona Institute’s Phase 2 study of psilocybin for Major Depressive Disorder (MDD).
Using admittedly crude math, one might assume that we can derive (at best) forty 25mg doses from a gram of psilocybin. This means that a federal production quota of 30g supports 1,200 25mg doses, while the new quota would allow for 60,000 doses.
Of course, a large portion of this psilocybin will be used in nonclinical work. Still, if one looks at the range of drug development efforts underway using psilocybin, it’s not surprising that many are excited about this proposal.
Not only would the proposed quota increase likely make it at least somewhat easier, and cheaper, to acquire psilocybin for research purposes, many also see it as a positive signal from the Administration, which wrote in its notice: “[the] DEA firmly believes in supporting regulated research of schedule I controlled substances,” and noted that the quota increases “are directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes.”
LA Times Op-Ed: Doctors Aren’t Prepared for Psychedelic Treatments
In an Op-Ed for LA Times, Rick Doblin and Jennifer Ouyang Altman argue that doctors aren’t prepared for the increased interest in, and usage of, psychedelics as therapeutics.
It’s not a question of whether people will use powerful psychedelics in pursuit of mental health. They do and they will. Let’s hope patients feel comfortable talking to their healthcare providers about it. When providers face that moment, they should know how to keep patients safe — and they should know better than to stand between ill patients and promising treatments.
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