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

On May 23, 2022, MAPS submitted a complete response to the U.S. Food and Drug Administration (FDA) addressing the concerns outlined in the continued partial clinical hold for MAPS-sponsored Study MPG1. The response included narrative information and additional details on the safety data provided in the prior response letter, as requested by FDA. This included clarification that many of the adverse events for which FDA requested more information began more than two days after the Experimental Sessions, indicating they were temporally unrelated to MDMA. Further, the majority of those that did begin within two days of an Experimental Session resolved the same day without intervention. The response maintained that exclusion of participant overnight stays for group treatment sessions does not present any unreasonable or significant risk to participants in Study MPG1 and requested that FDA agree to remove the clinical hold in consideration of the additional safety information provided.