The Food and Drug Administration has designated psilocybin mushrooms as a “Breakthrough Therapy” for Major Depressive Disorder (MDD), a move that will accelerate research and review of new medications developed with the hallucinogenic compound. The Breakthrough Therapy classification is designed to speed up the development and approval of new drugs.

The new Breakthrough Therapy designation for MDD, more commonly referred to as depression, was granted to Usona Institute, which recently launched a phase 2 clinical trial to determine the effectiveness of a single oral dose of psilocybin as a treatment for depression. The Usona Institute is a non-profit medical research organization that “conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines.” Usona is currently recruiting volunteers for the clinical trial.

At least 17 million adults in the United States have depression, the leading cause of disability in the nation for those 15-44. Worldwide, it is estimated that more than 300 million people have MDD. Prior research has shown that terminally ill patients who were treated with psilocybin showed a significant decrease in depression and anxiety. A similar study is being conducted in Melbourne, Australia.

“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,” said Charles Raison, MD,  the director of clinical and translational research at Usona, in a press release.

Not the First Time

This is the second time in just over a year that the FDA has designated psilocybin as a Breakthrough Therapy. In October, 2018, the agency granted the designation to COMPASS Pathways for its use of psilocybin as a treatment for treatment-resistant depression (TRD). TRD is defined as symptoms of depression that do not improve with the use of two or more traditional therapies. In October, the University of Texas Science Health Center in Houston (UTHealth) announced that researchers there would be conducting a study on the effectiveness of psilocybin as a treatment for TRD.

“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. “Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.”

Although psilocybin is listed as a Schedule I controlled substance at the federal level, local jurisdictions have begun to relax the laws prohibiting psychedelic mushrooms. In May, Denver residents voted to approve a measure that effectively decriminalized adult possession of psilocybin mushrooms by making enforcement of laws prohibiting them the city’s lowest law enforcement priority and prohibiting the use of public funds to prosecute offenses. The following month, a similar measure to decriminalize psilocybin mushrooms and other entheogenic plants was approved by city leaders in Oakland, California.

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