Wisconsin-based Usona Institute has been granted breakthrough therapy designation for psilocybin from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD).
According to Usona Institute, the designation secured by psilocybin for major depressive disorder acknowledges the unmet medical need in the broad population and also the potential for significant improvements over available therapies. Furthermore, it is said to strengthen the mission of Usona Institute to move ahead towards new drug approval.
Charles Raison – Usona Institute Director of Clinical and Translational Research 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 FDA breakthrough therapy status for psilocybin comes after the recent initiation of Usona Institute’s PSIL201 phase 2 clinical trial, which will have nearly 80 participants across seven study sites in the US. While a couple of the seven study sites are currently enrolling, the others are likely to be active by Q1 2020.