The filing marks the first New Drug Application (NDA) to the Food and Drug Administration (FDA) for MDMA paired with psychological intervention for the potential treatment of PTSD. If approved, it would become the first federally legal psychedelic-assisted therapy.
First Country Allowing MDMA & Psilocybin For Depression, PTSD Makes Headlines On Saturday, July 1, 2023, Australia became the first country to allow physicians to prescribe MDMA to treat post-traumatic stress disorder (PTSD) and psilocybin to combat treatment-resistant depression.