Usona Institute has received Breakthrough Therapy Designation from the US 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, and bolsters Usona’s mission to advance this revolutionary treatment paradigm toward new drug approval.
“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. What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” said Charles Raison, MD, Director of Clinical and Translational Research at Usona. “Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.”
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The new status follows the recent launch of Usona’s Phase 2 clinical trial, PSIL201, which will include approximately 80 participants at seven study sites around the US. Two of the seven study sites are currently recruiting, with the others expected to be active by the first quarter of 2020.