FDA/CDC

FDA fast-tracks psilocybin for major depressive disorder


 

Psilocybin, a short-acting compound that is the psychoactive ingredient in “magic mushrooms,” has received a Breakthrough Therapy designation from the Food and Drug Administration for the treatment of adults with major depressive disorder.

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The designation was given to the Usona Institute, a nonprofit medical research organization, and comes in the wake of Usona’s launch of a phase 2 clinical trial that will include about 80 participants at seven study sites across the United States, according to a press release. Two sites are currently recruiting patients, and the others are expected to begin recruiting in 2020.

Breakthrough Therapy designation as defined by the FDA means that, based on preliminary research, “the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.” In this case, psilocybin may offer significant improvement over current therapies for major depressive disorder. Usona is working with the University of Wisconsin’s University Hospital in Madison, and other collaborators, according to a presentation by Malynn Utzinger, MD, director of integrative medicine and cofounder of the organization.

More information on the Usona Institute and Usona’s clinical trials is available at https://usonaclinicaltrials.org/.

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