- Top-line data expected in the first quarter of 2023
- Data to be part of new drug application submission expected in third quarter of 2023
SAN JOSE, Calif., Nov. 17, 2022 /PRNewswire/ — MAPS Public Benefit Corporation (“MAPS PBC”), a private company dedicated to the development and commercialization of psychedelic medicines, announced the final participant visit has been completed in MAPP2, a multi-site Phase 3 study of MDMA-assisted therapy (“MDMA-AT”) for post-traumatic stress disorder (“PTSD”).
The top-line results are expected in the first quarter of 2023. This is the second of two Phase 3 pivotal trials and will be the basis for the New Drug Application (“NDA”) expected to be submitted to the U.S. Food and Drug Administration (“FDA”) in the third quarter of 2023. The FDA granted MDMA-AT Breakthrough Therapy Designation, a process designed to expedite development and review of drugs intended to treat serious conditions and that demonstrate substantial improvement over available therapies.
“The completion of our confirmatory Phase 3 study brings us closer to potentially achieving our goal of delivering MDMA-assisted therapy to the millions of Americans with PTSD who are grossly underserved by existing treatment options,” said Amy Emerson, chief executive officer, MAPS PBC. “This has been a decades-long journey born out of a desire to explore the potential of MDMA-assisted therapy to treat various mental health conditions. Our progress to date would not be possible without the tireless commitment of the investigators, therapists, clinical trial participants and of course MAPS and the thousands of donors who have funded our research to date.”
The first Phase 3 study, MAPP1, examined the safety and efficacy of MDMA-AT versus therapy with placebo control in treating individuals with severe PTSD. MAPP1 demonstrated that 88 percent of the participants treated with MDMA-AT had a clinically significant improvement in their PTSD symptoms and 67 percent no longer qualified for a PTSD diagnosis. The most common adverse events in the MDMA group were muscle tightness, decreased appetite, nausea, sweating, pupil dilation, and feeling cold; no serious adverse events were reported.
The completion of data gathering in our second Phase 3 study of MDMA-assisted therapy for PTSD is a critical milestone in MAPS’ 36-year campaign to obtain FDA approval for the therapeutic use of MDMA. I’m proud of our team of therapists, staff, donors, funders, and especially the brave patients who volunteered to confront their trauma in our studies. – Rick Doblin, Ph.D., Executive Director, MAPS
The MAPP2 study protocol was essentially the same as the first Phase 3 study with two primary differences. MAPP2 enrolled participants with moderate and severe PTSD, while participants in MAPP1 had severe PTSD. In addition, enrollment of people of color doubled with the total participants of color representing more than 50 percent of the total in the study.
MDMA-AT has not been approved by any regulatory agency. The safety and efficacy of MDMA-AT have not been established for the treatment of PTSD.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) is focused on developing and commercializing prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization.
SOURCE MAPS Public Benefit Corporationmdma psychedelic therapy breakthrough therapy ptsd breakthrough therapy designation fda research psychedelics