MAPS PBC announces submission of new drug application to the FDA for MDMA-assisted therapy for PTSD

• Filing marks first NDA submission for any psychedelic-assisted therapy
• Submission represents 30 plus years of clinical research into potential use of MDMA-assisted therapy for PTSD
• NDA includes two Phase 3 trials (MAPP1 and MAPP2) that both met primary and secondary endpoints

SAN JOSE, Calif., December 12, 2023—MAPS Public Benefit Corporation (“MAPS PBC”), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced the submission of a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider. This investigational MDMA-assisted therapy is in development for individuals with post-traumatic stress disorder (“PTSD”) and if approved, would be the first psychedelic-assisted therapy approved for PTSD.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” said Amy Emerson, chief executive officer, MAPS PBC. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”

The NDA submission included results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants diagnosed with moderate or moderate and severe PTSD, respectively. Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine. ^[1],[2] 

With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA grant Priority Review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Administration (“DEA”) would be required to reschedule MDMA making it available for prescription medical use.

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