In several ways, psychedelic therapy continued to make strides toward legitimization in 2022. Michael Pollan’s best-selling psychedelic treatise “How to Change Your Mind” formed the basis for a popular Netflix series. Several celebrities declared that psychedelics had improved their lives.

Decriminalization efforts gaining steam

Colorado decriminalized psychedelic plants, as did the city of San Francisco. (Several other U.S. cities have done so earlier.) On January 1, 2023, Oregon will authorize therapy based on the magic mushroom compound psilocybin under Ballot Measure 109, which passed in November 2020. The state will restrict the treatment to licensed facilities with therapists with specific training. In 2023, New York state and California could legalize natural psychedelics. In Canada, Quebec became the first province to authorize insurance coverage for psilocybin-based psychotherapy.

2022 was a bad year for public psychedelic therapy companies

Big Pharma’s decision to stay away from psychedelics seems to have been sound — at least in 2022. The year was rough for many companies aiming to develop psychedelics for mood disorders.

• In 2022, the psilocybin-focused company COMPASS Pathways (Nasdaq:CMPS) saw its stock fall 66%.
• The psychedelic company ATAI Life Sciences also saw its shares fall by 66%.
• Some companies fared worse. Cybin (NYSEAMERICAN: CYBN), Numinus Wellness (TSE:NUMI) and Revive Therapeutics (OTCMKTS:RVVTF) saw their stock price dip more than 70% over the year.
• MindMed (Nasdaq:MNMD) saw its share price plunge 90%. In June, the company received a notice of potential delisting from the Nasdaq.

For comparison, the Nasdaq Biotechnology Index fell 13% over 2022 while the Dow Jones U.S. Pharmaceuticals Index ticked up 4%. That said, 2022 was the worst year for stocks overall since 2008.

Clinical trial progress

Compass Pathways is currently running the first Phase 3 study for psilocybin — as a potential therapy for treatment-resistant depression. In November 2022, NEJM published an article describing the results of the company’s Phase 2b study evaluating a single dose of psilocybin for treatment-resistant depression. A single 25-mg dose reduced Montgomery–Åsberg Depression Rating Scale scores significantly. Still, the authors note that more extensive and longer clinical trials would be required to determine the safety and efficacy of psilocybin in depression.

In November, MAPS announced that it had completed a second Phase 3 “MAPP2” study of MDMA-assisted therapy to treat PTSD. It anticipates top-line data to be ready in the first quarter of 2023.

According to a leaked letter, the U.S. government is reportedly mulling approving psilocybin and MDMA in the coming years.

Psychedelic therapy risks

There are inherent risks involved in attempting to commercialize psychedelics, which remain Schedule I substances in the U.S. According to the DEA, they have no legitimate medical use, lack of safety for use with medical supervision and high abuse liability. In addition, psychedelics’ Schedule I status makes research difficult.

There continues to be a considerable degree of psychedelic hype, but the drug class come with adverse events. The potential widespread availability of psychedelics will lead to accidents and suicides, said veteran psychedelic researcher Dr. Rick Strassman in an interview in October.  “Another Charles Manson could crawl out of the swamp,” Strassman said. “It behooves academics and pharma to keep the lid on their unbridled enthusiasm [for psychedelics].”

It is also difficult to have strong patent protection for classic psychedelics like psilocybin. The Harvard Law Review notes that the U.S. Patent and Trademark Office (PTO) does not have substantial experience evaluating psychedelic compounds. In addition, patenting psychedelic therapies could “promote biopiracy, the exploitation of Indigenous knowledge without compensation,” the publication noted.

An evolving reputation?

As we noted in August, psychedelics also continue to have a reputational problem. For example, a 2021 Hill-HarrisX survey found that 65% of the public thought psychedelics had no legitimate medical use. Support was higher, however, for patients with mood disorders, according to a separate survey conducted by The Harris Poll on behalf of the ketamine company Delic Holdings. That survey found that 65% of Americans believed drugs such as ketamine, psilocybin and MDMA should be made available to patients with treatment-resistant anxiety, depression or PTSD.

But public support for decriminalization is also building. An article in JAMA Psychiatry noted that between January 2019 to September 2022, there was a sevenfold increase in proposed decriminalization bills introduced. There have been 74 bills and referendums in 25 states in that timeframe. Of those, 10 bills were enacted. Another 32 remained active at the time of publication. The authors of the JAMA article project that most U.S. states could legalize psychedelics from 2034 to 2037 based on an analytic model related to marijuana legalization.

The growing legalization efforts could mean that natural psychedelics follow a course similar to cannabis, which is legal for recreational or medical use in most U.S. states.

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Filed Under: Psychiatric/psychotropic drugs
Tagged With: psychedelic therapy
 

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