For the second time in two years, psilocybin, the trippy component of psychedelic mushrooms, has received a “breakthrough therapy” designation by the US Food and Drug Administration (FDA).
Before you break out the glowsticks, there are some caveats to keep in mind. First, this designation doesn’t mean anyone can just willy-nilly eat some shrooms with the government’s blessing. Rather, the FDA has given special permission to a medical research non-profit, the Usona Institute, to investigate psilocybin as a treatment for major depressive disorder (MDD). MDD is defined as persistent clinical depression that greatly increases the risk of self-harm, suicide, and other self-destructive behaviors. According to Healthline, roughly 16 million Americans currently live with an MDD diagnosis.
What’s a breakthrough therapy drug, and what does it mean when psilocybin receives this designation? The designation is a way for the FDA to expedite the development of a new, life saving drug for medical conditions that are difficult or impossible to treat with currently approved medications. And here’s the kicker: The FDA only assigns breakthrough therapy designation if the drug in question already has clinical evidence showing that it’s effective.
“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 Usona’s Director of Clinical and Translational Research, Dr. Charles Raison, MD, in a press release. “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,” Raison continued, “these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.”
The latest announcement marks the second time psilocybin received breakthrough therapy designation from the FDA. Last year, Compass Pathways, a pharmaceutical research firm, received the designation for studying psilocybin as a treatment for treatment-resistant depression.
Usona’s new breakthrough therapy designation came just as the non-profit began Phase II clinical trials for psilocybin and MDD. The current study will include 80 participants across seven US cities. The non-profit is currently recruiting new subjects in two of the seven cities – y’know, just in case you wanted to help their project along. Purely for scientific purposes, of course.
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