MAPS has announced further developments in its Phase 3 study of MDMA-assisted therapy for the treatment of PTSD.
MAPS has announced the final participant visit has been completed in MAPP2, a multi-site Phase 3 study of MDMA-assisted therapy for post-traumatic stress disorder (PTSD), with top-line results expected in the first quarter of 2023.
This is the second of two Phase 3 pivotal trials carried out by the company and will be the basis for the New Drug Application expected to be submitted to the US Food and Drug Administration (FDA) in the third quarter of next year.
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 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 per cent of the participants treated with MDMA-AT had a clinically significant improvement in their PTSD symptoms and 67 per cent 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 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, enrolment of people of colour doubled with the total participants of colour representing more than 50 per cent of the total in the study.
Amy Emerson, chief executive officer, MAPS PBC, commented: “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.
“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.”
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.
