FDA Grants Psilocybin Breakthrough Therapy Designation for Resistant Depression For Second Time

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This time last year, the FDA was designating psilocybin as a breakthrough therapy for depression for the very first time. “It really does represent a significant development in the whole history of psychedelic research,” said Charles Grob at the time, psychiatry and behavioral sciences professor at University of California, Los Angeles.


Now, the FDA has given it the designation for a second time with the Usona Institute.

“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in major depressive disorder (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.

New Atlas further breaks down the differences between last year’s designation and this year’s and why both are equally important:

“Last year’s Breakthrough Therapy designation was targeted at the drug’s efficacy for treatment-resistant depression (TRD). That particular clinical classification categorizes patients suffering from MDD who have not responded effectively to at least two different pharmacological antidepressant treatments during a current depressive episode. It is estimated between 10 and 30 percent of MDD patients fall into the category of TRD.

“The new FDA approval focuses on Usona’s research into the broader condition of MDD, characterized by episodes of severe depression that last more than two weeks. Hundreds of millions of people around the world suffer from these kinds of acute major depressive episodes every year.”

The phase 2 trial is expected to be completed by early 2021, and with the help of this status, Usona expects it to quickly move into a larger phase 3 trial.

via Medscape

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