- Results met study pre-specified primary and key secondary endpoints and will support new drug application submission expected in third quarter of 2023
- No serious adverse events observed in the MDMA group
- If approved, MAPS PBC’s MDMA-assisted therapy could be the first psychedelic-assisted therapy used to treat a mental health condition
SAN JOSE, Calif., January 5, 2023—MAPS Public Benefit Corporation (“MAPS PBC”), a private biopharmaceutical company dedicated to the development and commercialization of psychedelic medicines, announced positive results from MAPP2, a multi-site Phase 3 study of MDMA-assisted therapy for post–traumatic stress disorder (“PTSD”). The study met both the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (“CAPS-5”) and the key secondary endpoint of improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (“SDS”). No serious adverse events were observed in either the MDMA group or the control group.
“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer, MAPS PBC. “Now with two positive Phase 3 trials complete, we can add this important data to the new drug application which we expect to submit in the third quarter of this year.”
MAPP2 was a randomized, double-blind, multi-site Phase 3 study of the efficacy and safety of MDMA-assisted therapy for the treatment of PTSD. The study enrolled 121 participants and of those enrolled 104 were randomized to either a group that received 80 to 120 mg MDMA hydrochloride followed by a supplemental half-dose of 40 or 60 mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy. The MAPP2 study enrolled participants with PTSD for the 12-week treatment period. The MAPP2 participants reflected the U.S. demographics of those living with PTSD with people of color representing more than half of those enrolled in the study.
In 2017 the U.S. Food and Drug Administration (“FDA”) granted MDMA-assisted therapy 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. MAPS PBC expects to submit the new drug application to the FDA in the third quarter of 2023. MAPS PBC plans to submit the full data set for publication in a peer-reviewed journal.
MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy 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 to bring better treatments to those living with mental health conditions. Founded in 2014, MAPS PBC is a subsidiary of the Multidisciplinary Association for Psychedelic Studies, a 501(c)(3) non-profit organization.
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