Skip to main content

Psilocybin Receives Breakthrough Therapy Designation for MDD

November 26, 2019

The US Food and Drug Administration (FDA) recently granted Usona Institute, Madison, Wisconsin, the Breakthrough Therapy designation for psilocybin in the treatment of patients with major depressive disorder (MDD).

The designation formalizes the FDA’s commitment to an efficient development program investigating use of the psychedelic drug in MDD treatment, the Usona Institute said in a statement.

“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 and cochair of Psych Congress.

“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.”

Blog: A Turning Point for Psychedelics?

Psilocybin potentially offers a novel paradigm for MDD treatment, in which a short-acting compound imparts profound alterations in consciousness and could promote long-term remission of depressive symptoms.

Earlier this fall, Usona launched a Phase 2 trial of psilocybin for MDD. The PSIL201 clinical trial will include approximately 80 participants at 7 study sites throughout the United States. Two sites are currently recruiting, with the others expected to be active by the first quarter of 2020.

“Given that there is so much complexity with psilocybin and that Usona is charting new ground,” said Dr. Raison, “these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.”

—Jolynn Tumolo


FDA grants Breakthrough Therapy designation to Usona Institute's psilocybin program for major depressive disorder [press release]. Madison, Wisconsin: Usona Institute; November 22, 2019.

Back to Top