The FDA Fast-Tracks Its Review of Psilocybin and Methylone, 2 Promising Psychedelics

It has been six days since President Donald Trump signed an executive order aimed at facilitating regulatory review of psychedelics that have shown potential as psychotherapeutic catalysts. As promised then, the Food and Drug Administration (FDA) today issued “national priority vouchers” for two psychedelics: psilocybin as a treatment for depression and methylone (a.k.a. MDMC) as a treatment for post-traumatic stress disorder (PTSD).

The FDA had previously designated both drugs as “breakthrough” therapies, meaning they “may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.” Although that designation is supposed to streamline the review process, the vouchers go further, promising an “ultra-fast timeline” of one to two months, rather than six months or more, after the requisite studies are completed.

Psychedelics “have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” said FDA Commissioner Marty Makary. “As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”

The FDA recognized psilocybin as a breakthrough therapy in 2018 after preliminary studies found dramatic psychological improvements in subjects with “treatment-resistant major depression” and patients with life-threatening illnesses. Compass Pathways, a London-based biotechnology company, is conducting Phase 3 clinical trials aimed at winning FDA approval of its synthetic psilocybin as a prescription drug for people diagnosed with treatment-resistant depression.

The Usona Institute, a nonprofit organization based in Madison, Wisconsin, is conducting a Phase 3 trial of psilocybin as a treatment for people with a diagnosis of major depressive disorder. The FDA is also considering an application from Helus Pharma, a Canadian company formerly known as Cybin, which is conducting Phase 3 trials of psilocin, the active agent that psilocybin becomes after ingestion, for the same indication.

Last year, the FDA designated methylone, which is similar to MDMA, as a breakthrough therapy based on a Phase 2 trial that found “rapid, robust, and durable improvements” in subjects diagnosed with severe PTSD. Transcend Therapeutics, a neuropsychiatry company based in New York City, recently began Phase 3 trials of methylone as a PTSD treatment.

The Trump administration is “accelerating” the research and review necessary for “responsible access to promising mental health treatments,” including “psychedelic therapies like ibogaine,” said Secretary of Health and Human Services Robert F. Kennedy Jr. In addition to announcing the vouchers for psilocybin and methylone, the FDA said it had approved “an early phase clinical study” of ibogaine as “a potential treatment for alcohol use disorder.” It is the first human study of ibogaine, which also has promise as a PTSD treatment, to be approved in the United States.

“This is significant in that it speeds up access,” Melissa Lavasani, founder and chief executive of the Psychedelic Medicine Coalition, told CNN after Trump issued his executive order. “It speeds up these drugs being available on the market, and it can advance dialogues about what insurance coverage is going to look like and what health care infrastructure needs to be.” But “it’s going to be a trial-and-error process, and it’s not going to happen overnight,” she added. “Even with an executive order, this stuff takes a lot of time.”