The US Food and Drug Administration (FDA) has granted the Usona Institute breakthrough therapy designation for psilocybin for the treatment of major depressive disorder (MDD).
This marks the second time the FDA has granted breakthrough designation for psilocybin, the psychoactive ingredient in “magic mushrooms.”
“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,” Charles Raison, MD, Usona’s director of clinical and translational research, said a news release.
The Usona Institute is a nonprofit medical research organization that conducts and supports preclinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines.
“What is truly groundbreaking is FDA’s rightful acknowledgment 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 Raison.
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