MAPS Wins Appeal and Authorization to Study MDMA in Healthy Volunteer Therapists
On May 12, 2021, we announced that The U.S. Food and Drug Administration (FDA) Office of Neuroscience granted our appeal of the clinical hold on our Phase 1 study after almost two years of clinical hold. Initially placed on clinical hold by the FDA in 2019, the MT2 study protocol is a Phase 1, open-label, multi-site research study to assess the safety and psychological effects of MDMA-assisted therapy in healthy volunteer therapists undergoing training to treat patients suffering from posttraumatic stress disorder (PTSD) with MDMA-assisted therapy, developed by MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS. Personal experience is widely considered to be an important element in preparation and training to deliver psychedelic-assisted therapies.
The hold, lifted on May 11, 2021, was placed by the FDA due to concerns about the scientific merit of the study, risk-to-benefit ratio for healthy therapist participants, and the credentials of clinical investigators. If MAPS’ appeal was not granted, the hold would have required that the Lead Facilitator in each two-person facilitator team hold an M.D., Ph.D., or equivalent degree and that the physician be on-site instead of on-call during the treatment sessions. Read the full press release here.