FDA Places Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans (MPG1) On Clinical Hold

On February 28, 2022, the U.S. Food and Drug Administration (FDA) placed Study MPG1 on partial clinical hold, preventing the study from being initiated. FDA highlighted their concerns in the Partial Clinical Hold letter, which classified the safety risk of Study MPG1 not requiring overnight stay for participants as an unreasonable and significant risk to human subjects. The letter did not include substantive comment or acknowledgement of the rationale provided in the initial submission cover letter for Study MPG1. MAPS will request clarification on the Division’s view on safety considerations related to overnight stays to move this study forward as soon as possible.