Lexology December 20, 2023
MAPS PBC Submission for Approval of MDMA Is a First for Psychedelic-Assisted Therapy
On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC) announced their submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA (midomafetamine) in combination with psychotherapy for the treatment of post-traumatic stress disorder (PTSD).1 This marks the first NDA submission for any psychedelic-assisted therapy and is a major milestone for the medicinal psychedelics industry.
MDMA, often grouped in the category of psychedelics, is a synthetic psychoactive compound classified as an entactogen — meaning it induces emotional states such as openness and oneness. Mental health professionals were already using MDMA in combination with psychotherapy to...
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