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

On April 15, 2022, the U.S. Food and Drug Administration (FDA) upheld a partial clinical hold on Study MPG1, preventing the study from being initiated. FDA did not address specific questions from the previous response to the clinical hold, submitted on March 17, 2022, but requested more in-depth information on safety data to further assess potential risk of not requiring overnight stay for participants. MAPS appreciates the FDA’s engagement with the study data and looks forward to providing a thorough response to their latest inquiry with the hope of removing Study MPG1 from clinical hold.