New Drug Application to U.S. FDA for MDMA-Assisted Therapy for PTSD

MAPS PBC, a clinical stage company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy in treating post-traumatic stress disorder (PTSD). This marks the first instance of a psychedelic-assisted therapy being considered for FDA approval, potentially introducing a novel treatment option for adults with PTSD. The NDA, reflecting over 30 years of research and collaboration, includes data from successful Phase 3 studies, and if approved, MDMA-assisted therapy could pave the way for increased investment in mental health research.

Read the full news release here.