FDA Agrees to Phase 3 Trials of MDMA-Assisted Therapy for PTSD

On November 29, 2016, the U.S. Food and Drug Administration (FDA) hosted staff and researchers at MAPS and the MAPS Public Benefit Corporation (MPBC) for a formal End of Phase 2 Meeting to discuss clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). During the 90-minute meeting at the FDA’s White Oak Campus in Silver Spring, Maryland, the FDA stated they are now ready for MAPS to move forward with Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. The formal approval of the Phase 3 trial protocol is expected by mid-April 2017.

On November 30, 2016, The New York Times published a feature article announcing the outcome of our End of Phase 2 meeting with the FDA. Trial participants Ed Thompson and CJ Hardin spoke with the NYTimes about how MDMA-assisted psychotherapy helped them overcome treatment-resistant PTSD. “It changed my life,” explains Ed. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward.” CJ speaks about the results from his treatment, stating, “The MDMA sessions showed me a light I could move toward. Now I’m out of the darkness and the world is all around me.”

We expect to initiate our first Phase 3 clinical trial in June 2017, which will last 2-3 years and enroll at least 230 participants. We are working with the FDA’s guidance on determining the final form of the Phase 3 trials, including selection of appropriate control group and sample size.

We need to raise approximately $25 million to complete these Phase 3 trial and all associated toxicity and pharmacology studiesover the next 5 years.Phase 3 trials are the final stage of research needed before the FDA will decide whether to approve MDMA-assisted psychotherapy as a prescription treatment for PTSD. There is now a clear path ahead to make MDMA a legal medicine for millions of people suffering from PTSD. Learn more…