The Food and Drug Administration announced Wednesday it will convene a public advisory committee meeting next month to evaluate a drug application for MDMA as a treatment for post-traumatic stress disorder.
In a federal notice, the FDA said the Psychopharmacologic Drugs Advisory Committee will discuss the overall benefit-risk profile and potential public health impact of Lykos Therapeutics‘ application for MDMA capsules on June 4. The committee provides nonbinding recommendations to the agency.
Lykos Therapeutics was previously known as MAPS Public Benefit Corp.
The daylong meeting in Silver Spring, Maryland, will be open to the public both in-person and remotely. It will focus on Lykos’ new drug application for MDMA capsules “for the proposed indication of treatment of post-traumatic stress disorder,” according to the FDA notice.
The committee’s expert advisers will weigh clinical data on the drug’s safety and efficacy. Presentations from FDA staff, the company, and public comments are expected before the panel votes on a recommendation regarding approval.
If cleared, MDMA (midomafetamine) would continue to be a federally controlled substance because of its psychedelic properties, but it could represent a new avenue for treating PTSD, a difficult-to-treat condition affecting millions of Americans.
MDMA was popularized as a party drug in the 1980s but has shown promise in clinical trials for helping people with PTSD when combined with counseling. It produces feelings of euphoria, emotional warmth, and distorted perception of time.
The FDA previously designated MDMA as a “breakthrough therapy” to expedite its development and review. A decision on Lykos’ application is expected by late summer.
The agency will take public comments on the application until June 3. Meeting background materials will be posted online by June 2.
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