Usona Institute has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for psilocybin in the treatmentof 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, and bolsters Usona’s mission to advance this revolutionary treatment paradigm toward new drug approval.