FDA Comments on Special Protocol Assessment (SPA) for Phase 3 Trials of MDMA-Assisted Therapy for PTSD

On June 13, as part of FDA’s Special Protocol Assessment process, MAPS submitted to FDA a revised Phase 3 protocol evaluating MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The protocol was revised based on discussions between MAPS and FDA during our May 11, 2017 Type A meeting and on FDA’s official meeting minutes we received on May 30, 2017. Based on the agreements reached during the May 11 Type A meeting we’re hopeful this will be our final revision.

Donations are currently being sought to reach MAPS’ goal of raising $25 million, with $10 million already raised, to successfully execute the Phase 3 studies required to gain approval from FDA for MDMA-assisted psychotherapy by 2021. Learn more…

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