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The second of a phase 3 study examining MDMA-AT just completed its final participant visit.
The final participant visit is complete in MAPP2, a multi-site phase 3 study of MDMA-assisted therapy (“MDMA-AT”) for posttraumatic stress disorder (PTSD), according to reports.1
“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 at MAPS Public Benefit Corporation. “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.”
MAPP2 is the second of 2 phase 3 trials studying MDMA-AT. The study’s protocol was essentially the same as MAPP1 with 2 primary differences: (1) MAPP2 enrolled participants with moderate and severe PTSD, while participants in MAPP1 had severe PTSD, (2) people of color enrolled at double the rate in MAPP2 with the total participants of color representing more than 50% of the total in the study. MAPP2 will be the groundwork for the New Drug Application expected to be submitted to the US Food and Drug Administration (FDA) midway through 2023. The FDA has already granted MDMA-AT Breakthrough Therapy Designation.
MAPP1 examined the safety and efficacy of MDMA-AT versus placebo control in treating individuals with severe PTSD. The results showed that 88% of the participants treated with MDMA-AT had a clinically significant improvement in their PTSD symptoms and 67% no longer qualified for a PTSD diagnosis. Common adverse events included muscle tightness, decreased appetite, nausea, sweating, pupil dilation, and feeling cold. No serious adverse events were reported.
1. MAPS PBC completes second phase 3 “MAPP2” trial of MDMA-assisted therapy for treatment of PTSD. MAPS Public Benefit Corporation. News release. November 17, 2022. Accessed November 18, 2022. https://mapspublicbenefit.com/press-releases/mapp2-completion-announcement/