FDA grants Breakthrough Therapy Designation to Usona Institute’s psilocybin program for major depressive disorder

MADISON, Wis.–(BUSINESS WIRE)–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,” says 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.”

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.

Significance for Patients Suffering from MDD

This is a significant milestone for the over 17 million people in the US who suffer from MDD. Although there are several existing MDD treatments, Breakthrough Therapy Designation recognizes that psilocybin may offer a clinically significant improvement over these therapies. Psilocybin potentially offers a novel paradigm in which a short-acting compound imparts profound alterations in consciousness and could enable long-term remission of depressive symptoms.

Depression is the world’s leading cause of disability, affecting more than 300 million people worldwide. With such a broad potential impact, this designation represents a major step forward in mental health research and for patients suffering from depression.

For more information on Usona’s ongoing clinical trials, please visit www.usonaclinicaltrials.org.

Usona Institute is a 501(c)(3) nonprofit medical research organization (MRO) that conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Its focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life.

Contacts

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