Multidisciplinary Association for Psychedelic Studies, or MAPS, said Thursday that it plans to apply for a New Drug Application (NDA) with the U.S. Food and Drug Administration after positive results on a second, confirmatory Phase 3 trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD) were published in “Nature Medicine”. MAPS Public Benefit Corp. plans to collect data from 18 Phase 2 and Phase 3 studies in its NDA, which is expects to file later this year. Rick Doblin, founder and president of MAPS, said MDMA-assisted PTSD therapy is on track for potential FDA approval in 2024.
