New FDA guidance meant to steer clinical trials of psychedelic compounds will play a major role in the eventual approval and commercialization of new drugs that incorporate ingredients like psilocybin. The world’s first phase 3 trial of a psychedelic medicine is currently underway and has received FDA feedback in its pursuit of continued positive results.
Lawmakers and their constituents alike are shifting their support toward the implementation of new legal frameworks which allow the employment of psychedelic therapies in a medicinal capacity – a key factor that will determine the level of investor interest and institutional fundraising for the industry.
Related Stocks: Mind Medicine Inc. (MNMD), COMPASS Pathways plc (CMPS), Atai Life Sciences N.V. (ATAI), Cybin Inc. (CYBN)
Late last month, the US Food and Drug Administration (FDA) set forth guidance for drug trials on hallucinatory compounds like LSD or psilocybin, as well as other so-called psychedelic drugs like ketamine or MDMA, for the first time. A growing body of research on these treatments is already well-established, focusing on the treatment of post-traumatic stress disorder, depression and other mental health conditions, but these new guidelines will “help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications,” according to Tiffany Farchione, director of the FDA’s Division of Psychiatry. A 60-day public comment period is open for interested parties to submit feedback on how final guidance should be further shaped.
Clinical trials of compounds like psilocybin have yielded plenty of impressive results over the past several years, and those findings can now be molded into proper conformity with FDA guidance to bolster commercialization efforts. In January, MRP noted that a successful phase 2B trial of psilocybin sponsored by COMPASS Pathways PLC, a mental health care company focused on the use of innovative therapies to treat depression, and published in The New England Journal of Medicine, would soon expand into the world’s first phase 3 trial of the compound, which will include two clinical trials, testing of multiple dosages instead of a single dose, as well as a long-term follow-up that could enroll nearly 1,000 patients. In phase 2B, results showed…
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