On November 8, 2021, MAPS submitted a new study protocol to the U.S. Food and Drug Administration (FDA) for a Phase 2 open-label feasibility and safety study of MDMA-assisted group therapy for the treatment of posttraumatic stress disorder in veterans (Study MPG1). Administration of MDMA-assisted therapy in a group therapy model is key to supporting accessibility, which is a critical goal for MAPS.
As has been requested by the FDA, this initial submission highlighted the potential review issue with Study MPG1’s proposal not to include participant overnight stays at the study site for this small proof-of-concept group therapy study. This letter included a justification based on absence of safety signals in the sub-study examining the effect of removing the requirement for overnight stays in the Phase 3 Study MAPP1.