On June 22, 2017, MAPS submitted to the U.S. Food and Drug Administration (FDA) an application for Breakthrough Therapy designation for our upcoming Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). If approved, Breakthrough Therapy designation could expedite the development and review of MDMA-assisted psychotherapy for PTSD.
On June 27, the U.S. Food and Drug Administration (FDA) provided clearance for the initiation of our upcoming open-label Phase 2 study of MDMA-assisted psychotherapy for PTSD, taking place at all upcoming Phase 3 study sites in the United States. Participants with PTSD will receive MDMA-assisted psychotherapy from supervised co-therapy teams who will receive supervision by our our adherence raters and clinical training team in order to provide necessary experience for therapists transitioning to Phase 3 trials. Site initiation visits will begin in August and continue through September.
Our revised Phase 3 protocol evaluating MDMA-assisted psychotherapy for PTSD was granted unconditional approval by the Copernicus Group Institutional Review Board (IRB) on June 27. We expect to receive a response from the FDA regarding the Special Protocol Assessment process and our revised Phase 3 protocol by July 27.
Donations are currently being sought to reach MAPS’ goal of raising $25 million, with $10 million already raised, to successfully execute the Phase 3 studies required to gain approval from FDA for MDMA-assisted psychotherapy by 2021.