FDA Grants Breakthrough Therapy Designation to Study Magic Mushrooms as Alternative Treatment

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The Food and Drug Administration has granted a second “breakthrough therapy” designation to the Usona Institute to research psilocybin, AKA magic mushrooms, as an alternative treatment for major depressive disorder (MDD).

In October 2018, Compass Pathways was granted the first FDA designation to study the effects of psilocybin on treatment-resistant depression. Results from that study are expected sometime next year. 

“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,” said Charles Raison, MD, Usona’s Director of Clinical and Translational Research.

MDD can sometimes be drug-resistant, meaning individuals are often unsuccessful in treating or managing depression with the traditional classes of drugs like SSRIs and MAOIs. 

Research on MDMA—the main, uncut ingredient found in ecstasy—as a treatment for PTSD has yielded similar results. A growing number of studies have found that mushrooms may help alleviate addiction issues, anxiety, depression and obsessive-compulsive disorders.

“You have this mountain of studies until about 1970, and then it stops,” said Raison. “There was a hiatus of 26 or 27 years where research was just killed, and when it started again there were significant difficulties and significant pressure. It was really a challenge.”

Raison says that had this research continued into the 1980s, when modern pharmacology began to take off, he’s certain that “we’d be living in a totally different world.”

In May, Denver became the first city to decriminalize psilocybin, and Oakland followed suit a month later. While the drug remains illegal federally, the two cities have deprioritized mushrooms for law enforcement. There haven’t been any psilocybin charges since the Denver’s ordinance was passed. In a handful of cases where suspected mushrooms were found, arrests were made on other charges.

Two research sites in Florida and New York are currently recruiting test subjects for the Usona trials, and sites in Chicago, Baltimore, San Francisco, Madison and New Haven will begin accepting applications soon.