FDA: Psilocybin granted NEW BREAKTHROUGH Therapy for major depressive disorder (Usona Institute) (Patreon)

Published:

2019-11-25 22:18:11

Imported:

2023-10

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The FDA just granted another breakthrough therapy designation for psilocybin, this time to a startup called "Usona Institute" for treatment of major depressive disorder (MDD). This is the second such designation since Compass Pathways (a startup with venture funding from Peter Thiel) received this for using psilicybin in treatment resistant depression. This new broader FDA action and the associated Usona trials are significant because major depressive disorder affects approximately 14.8 million American adults, or about 6.7 percent of the U.S. population age 18 and older in a given year and is the leading cause of disability in the U.S. for ages 15-44 (source). Usona reps were are the recent Horizons conference I attended, where they reported that they had recently completed their treatment protocol guidebook (their method involves numerous pre and post psilocybin sessions with a trained psychiatrist including pre-flight preparation as well as post-flight integration work). They are enrolling volunteers right now for clinical trials.

I eagerly await the results of their clinical trials. If you know anyone in the U.S. with major depressive disorder, you may wish to inform them of these ongoing trials.

In other news, check out this Today Show segment on Psilocybin.

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Psilocybin for major depression granted Breakthrough Therapy by FDA

The US Food and Drug Administration (FDA) has granted psilocybin therapy a Breakthrough Therapy designation for the second time in a year, this time with a view on accelerating trials testing its efficacy treating major depressive disorder (MDD).