FDA Fast-Tracks Psilocybin Treatment for Depression

The Usona Institute just received a “breakthrough therapy” designation

A new announcement from the FDA is encouraging for efforts to use psilocybin to treat depression.
Scienceman71/Creative Commons

As candid discourse about mental-health issues takes root, there’s been a surge in discussion surrounding psilocybin’s effectiveness at treating depression. It’s not a new thing so much as a very old thing: there’s a long history of magic mushrooms being consumed for sacred purposes, and in more recent years, scientists have come on board, with the idea of psilocybin being used to treat depression accruing formal support. 

But there’s still the matter of legality: whether you’re looking to address your depression or opting for the benefits of microdosing, accessing psilocybin legally isn’t easy. Magic mushrooms are legal in all of two cities in the United States. But that might be about to change, and sooner that you might think.

Gizmodo is reporting that the FDA has designated the Usona Institute’s work using psilocybin to treat clinical depression as a “breakthrough therapy.” That’s a formal designation, and is one designed to help speed up the review process for evaluating this treatment. Last year, the FDA applied a similar designation to Compass Pathways — a company which began in the nonprofit space before becoming a for-profit corporation.

Gizmodo’s Ed Cara writes that “the new designation, given to the Wisconsin-based organization Usona Institute, is even more meaningful since it’s for the development of psilocybin as a standard treatment for clinical depression.”

The Usona Institute’s website cites its founder, Bill Linton, as having started the nonprofit due to “the meaningful impact that a psilocybin study at Johns Hopkins University had on a friend suffering from cancer.” Next year, they hope to begin a Phase 2 trial; ff successful, a larger Phase III trial would follow.

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