FDA Accelerates Psilocybin Research For Major Depressive Disorder

FDA Accelerates Psilocybin Research For Major Depressive Disorder

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…

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Source : High Times
Link to original : FDA Accelerates Psilocybin Research For Major Depressive Disorder
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