FDA Receives Application for Approval of MDMA-Assisted Therapy | Manatt, Phelps & Phillips, LLP

On December 12, 2023, the MAPS Public Benefit Corporation (MAPS PBC) announced the submission of a marketing application to the U.S. Food and Drug Administration (FDA) for MDMA (midomafetamine capsules) in combination with psychological intervention by a qualified health care provider (including psychotherapy, talk therapy and other supportive services) for use in individuals with post-traumatic stress disorder (PTSD). If FDA approves the application, MDMA-assisted therapy would become the first psychedelic-assisted therapy approved for treatment of PTSD.

FDA must decide whether to accept the application within 60 days. If the application is accepted, FDA must then decide whether to grant priority review (approval decision within six months) or standard review (approval decision within ten months).

According to the MAPS PBC press release, the application included “numerous studies” including two randomized controlled phase 3 studies that met both their primary and secondary endpoints, without any serious adverse events reported.

The MAPS PBC application comes on the heels of significant focus at the federal level on the promise of psychedelics for treating an array of mental and behavioral health conditions, including the release of a first-of-its kind FDA draft guidance for sponsors of studies of psychedelic drugs, as noted in our previous newsletter.

Other psychedelics are being studied and are showing promise as “potential treatments for mood, anxiety and substance use disorders,” according to FDA. COMPASS Pathways is studying a synthetic formulation of psilocybin, “COMP360,” in treatment-resistant depression.

2024 is poised to be a significant year in the rapidly growing field of the study of psychedelics.

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