Psilocybin Designated Breakthrough Tx for Major Depressive Disorder

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorder (MDD). The psilocybin development program for MDD is being conducted by the Usona Institute, a non-profit medical research organization.

Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I drug as it has not been approved by the FDA for any therapeutic use. Usona recently initiated a phase 2 trial that will evaluate the potential efficacy of a single 25mg oral dose of psilocybin in 80 adult patients with MDD; the trial will use niacin (100mg dose) as the active placebo. The primary end point will be change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to post-dose Day 8.

“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, Director of Clinical and Translational Research at Usona. 

A recent review evaluating the abuse potential of medical psilocybin found that compared to typical drugs of abuse, the potential harms associated with psilocybin seem low and are manageable when administered according to a medical model that addresses these concerns.

For more information visit usonaclinicaltrials.org.