FDA Grants Breakthrough Therapy Designation To Usona Institute’s Psilocybin Program For Major Depressive Disorder

Usona Institute has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for psilocybin in the treatment of major depressive disorder (MDD). Breakthrough Therapy Designation establishes FDA’s organizational commitment to promoting an efficient development program for psilocybin in MDD. The designation of psilocybin as a Breakthrough Therapy for MDD acknowledges both the unmet medical need in this broad population and the potential for significant improvements over existing therapies. It also bolsters Usona’s mission to advance this revolutionary treatment paradigm toward new drug approval.

The new status follows the recent launch of Usona’s Phase . . .