The FDA designation represents a major step forward in mental health research and for patients suffering from depression.
A non-profit medical research centre, the Usona Institute, has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) of psilocybin for major depressive disorder (MDD).
Psilocybin, the active compound found in hundreds of mushrooms and some plants across the world, colloquially known as ‘magic mushrooms’, has been marked as a Schedule 1 illegal substance in America since the 70’s.
Depression is the world’s leading cause of disability, affecting more than 300 million people worldwide.
The institute will now begin Phase 2 clinical trials testing the efficacy of psilocybin for major depressive disorder in the aim to advance the revolutionary treatment towards new drug approval.
Breakthrough Therapy Designation
The designation of psilocybin as a Breakthrough Therapy for MDD acknowledges the unmet medical need in this broad population and the potential for significant improvements over existing therapies.
Charles Raison, MD, Director of Clinical and Translational Research at Usona, said: “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.
“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.
Significant milestone for major depression
The move marks a significant milestone for over 17 million people in the US who suffer from major depressive disorder. Although there are several existing treatments, Breakthrough Therapy Designation recognises 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.