Usona Institute's Psilocybin Program for Major Depressive Disorder Granted FDA Breakthrough Therapy Designation

VCBeat (WeChat ID: vcbeat) learned from foreign media that on November 22, 2019, local time, the Usona Institute announced that its psilocybin therapy for major depressive disorder (MDD) had received Breakthrough Therapy Designation from the U.S. FDA.

Breakthrough Therapy designation signifies the FDA’s commitment to efficient drug development and enhanced guidance, substantially reducing average development time compared with other FDA priority programs or drugs without priority designation.

Headquartered in Madison, Wisconsin, USA, Usona Institute is a non-profit medical research organization (MRO) founded in 2014 by Bill Linton, Founder and CEO of Promega Corporation, and Malynn Utzinger, Director of Integrated Operations. Usona conducts and supports preclinical and clinical research to further understand the efficacy of psilocybin and other psychedelic therapeutics, with a focus on alleviating depression and anxiety.

Psilocybin is a naturally occurring compound found in various species of Psilocybe mushrooms. Psilocybin, along with lysergic acid diethylamide (LSD), belongs to the class of psychedelic therapeutics, commonly referred to as "classic hallucinogens." Classic hallucinogens are typically non-addictive and can enhance or alter patients' states of consciousness through sensory perceptions, such as illusions, synesthesia, and distorted proprioception. Upon entering the body, psilocybin undergoes enzymatic dephosphorylation to produce psilocin. Psilocin is an agonist at multiple serotonin receptors (including 5-HT2A receptors3,4) and plays a significant role in regulating behavior, cognitive function, and motor function.

In 1957, Swiss chemist Dr. Albert Hofmann first isolated psilocybin from Psilocybe mushrooms and subsequently resynthesized it in 1958. In the 1960s, Sandoz introduced its psilocybin product, Indocybin, to the market for use in experimental research and psychotherapy. However, due to concerns about the potential misuse of psilocybin owing to its hallucinogenic properties, the substance was listed in Schedule I of the Controlled Substances Act in 1970, thereby excluding it from clinical use and scientific research.

Usona Institute stated that although psilocybin remains a controlled substance in the United States, contemporary studies have demonstrated its potential therapeutic benefits for various mental disorders when administered in a supportive psychotherapeutic setting.

The Usona Institute website specifically notes that any FDA-approved psilocybin research sponsored by Usona involves the administration of psilocybin or placebo as part of a carefully designed and controlled treatment protocol, and that the investigational drug is permitted to be administered only under the clinical supervision of trained and qualified therapists.

(Compiled by He Li)