Manatt Health December 13, 2023
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...
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