FDA accelerates research on psilocybin for major depressive disorder

The Food and Drug Administration The FDA has classified hallucinogenic mushrooms as a «breakthrough therapy» for major depressive disorder (MDD), a move that will accelerate research into new drugs based on psilocybin. This classification was established in 2012 to provide a framework for the research and development of drugs derived from substances that show significant potential compared to existing options and are intended for patients with serious or life-threatening conditions.

The first study on the «revolutionary therapy» for depression was conducted by the Usona Institute, which has just launched a Phase II clinical trial to determine the efficacy of a single oral dose of psilocybin in treating depression. The Usona Institute is a nonprofit medical research organization that «conducts and supports preclinical and clinical research to better understand the therapeutic effects of psilocybin and other consciousness-expanding drugs.» Usona is currently recruiting volunteers for the clinical trial.

In the United States, at least 17 million adults suffer from depression, the leading cause of disability in the country among people aged 15 to 44, representing 7% of the population. In France, estimates range from 8 to 10% of the population. Previous research has shown that terminally ill patients treated with psilocybin exhibited a a significant reduction in depression and anxiety. A similar study is underway in Melbourne, Australia.

«The results of previous studies clearly demonstrate psilocybin's remarkable potential as a treatment for patients with MDD, which Usona is now seeking to confirm in its own clinical trials,» said declared Charles Raison, MD, Director of Clinical and Translational Research at Usona.

Although psilocybin is listed as a controlled substance in the United States, in Schedule I alongside cannabis, some local jurisdictions have begun to relax their laws regarding hallucinogenic mushrooms. In May, Denver residents voted in favor of a measure to decriminalize the possession of psilocybin mushrooms by adults. The following month, a similar measure to decriminalize the possession of psilocybin mushrooms and other entheogenic plants was approved by city officials in Oakland, California.

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 approval to conduct a study on the use of psilocybin as a treatment for treatment-resistant depression.