Protocol Review Period Passes, MAPS PBC Follows Up with FDA in Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans (MPG1)


On December 8, 2021, the 30 day protocol review period passed for our open-label feasibility and safety study of MDMA-assisted group therapy for the treatment of posttraumatic stress disorder in Veterans (MPG1). The protocol for this study was submitted to the U.S. Food and Drug Administration (FDA) for review and approval on November 8, 2021, by researchers from MAPS Public Benefit Corporation (MAPS PBC). The research team has sent an inquiry to the FDA asking if any comments were anticipated on the protocol.