FDA and MAPS Agree on Protocol for Phase 3 Trials of MDMA-Assisted Therapy for PTSD

On May 11, 2017 MAPS and MPBC staff held a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the upcoming Phase 3 clinical trial of MDMA-assisted psychotherapy for PTSD. At the meeting, all of the FDA’s concerns were addressed and no outstanding questions remain.

There are no road blocks to moving forward with Phase 3 as the FDA gave favorable feedback to MAPS and MPBC’s responses to FDA questions. With this collaborative meeting, we will be able to move forward with re-submitting the protocol and our Statistical Analysis Plan, the next step in the Special Protocol Assessment process. MAPS’ submission will go to FDA after it sends us official minutes of the May 11 teleconference by mid-June.

The review period after the next submission will be a month and a half. MAPS and MPBC staff are optimistic and excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted Psychotherapy. 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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