FDA Grants Psilocybin Second Breakthrough Therapy Designation for Resistant Depression

Megan Brooks

November 25, 2019

The US Food and Drug Administration (FDA) has granted the Usona Institute breakthrough therapy designation for psilocybin for the treatment of major depressive disorder (MDD).

This marks the second time the FDA has granted breakthrough designation for psilocybin, the psychoactive ingredient in "magic mushrooms."

In October 2018, Compass Pathways received the designation to test the safety and efficacy of psilocybin-assisted therapy for treatment-resistant depression, as reported by Medscape Medical News.

"The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials," Charles Raison, MD, Usona's director of clinical and translational research, said a news release.

The Usona Institute is a nonprofit medical research organization that conducts and supports preclinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines.

"What is truly groundbreaking is FDA's rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies," said Raison.

More than 17 million people in the United States suffer from MDD. Through the breakthrough therapy designation, psilocybin is recognized as possibly offering a clinically significant improvement over existing therapies.

The new status follows the recent launch of Usona's phase 2 clinical trial (PSIL201), which will recruit roughly 80 patients at seven study sites around the United States. The study will assess the safety and efficacy of a single dose of psilocybin in comparison with placebo in patients aged 21 to 65 years who have MDD.

Two of the study sites are currently recruiting patients; the others are expected to be active by the first quarter of 2020. Usona estimates that the trial will be completed by early 2021.

More information on the trial is available online.

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