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The Food and Drug Administration (FDA) is taking the next step in its historic review of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), scheduling a meeting next month where an expert committee will examine the evidence behind the application.
Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced on Monday that FDA's Psychopharmacologic Drugs Advisory Committee will meet on June 4 to review the results of its clinical trials for the psychedelic-assisted therapy.
Not only will this be the first time in 25 years since FDA has reviewed a new PTSD treatment option, it's the first time in history that the agency has taken up a new drug application for a psychedelic substance.
Amy Emerson, CEO of Lykos Therapeutics, said it is a "significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy."
"We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD," she said.
FDA's expert panel will look at an extensive body of research that includes two randomized, double-blind, placebo-controlled Phase 3 studies that looked at the safety and efficacy of MDMA-assisted therapy.
The committee review will take place about four months after FDA accepted the MDMA new drug application and granted it a priority status.
If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with talk therapy and other supportive services.
FDA in 2017 designated MDMA as a "breakthrough therapy" based on previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.
Last year, FDA released first-of-its-kind draft guidance on the "unique" considerations that researchers should take into account when studying psychedelics, which the agency says show "initial promise" as potential therapies.
Shortly after the MDMA capsule NDA was submitted to FDA, new standards from the American Medical Association (AMA) took effect in January that assign psychedelics-specific codes to collect data on the novel therapies.
Meanwhile, a separate study by researchers at New York University's Langone Center for Psychedelic Medicine and the Centre for Psychedelic Research at Imperial College London recently found that pairing MDMA with either psilocybin or LSD helped people overcome the "challenging experiences" associated with use of psilocybin or LSD alone.
In 2022, the Biden administration said it was "actively exploring" the possibility of creating a federal task force to investigate the therapeutic potential of psilocybin, MDMA and others ahead of the anticipated approval of the substances for prescription use.
Bipartisan congressional lawmakers asked the U.S. Department of Veterans Affairs (VA) last month to produce a plan to begin providing MDMA-assisted therapy for veterans as soon as the psychedelic is approved by FDA.
Also, proposed changes to federal workforce drug testing guidelines that are currently being reviewed by officials would remove screening for MDMA—which has only rarely appeared in workers' urine samples during recent years—and add testing for fentanyl, a substance that's become far more widespread in unregulated drug markets over the past decade.
