The investigational MDMA-assisted therapy is in development for treating PTSD.
MAPS Public Benefit Corp. said it has submitted a new-drug application to the U.S. Food and Drug Administration for MDMA (midomafetamine capsules) used in combination with psychological intervention.
The investigational MDMA-assisted therapy is in development for treating post-traumatic stress disorder (PTSD).
Psychological intervention could include psychotherapy – also known as talk therapy – and other supportive services provided by a qualified health care provider, the company noted.
“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 for 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 highlights 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 the results were published in the journal Nature Medicine.
With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA to 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 10 months, respectively).
MDMA-assisted therapy has not been approved by any regulatory agency. If approved by the FDA, the U.S. Drug Enforcement Agency would be required to reschedule MDMA, making it available for prescription medical use.
Founded in 2014, MAPS PBC is a for-profit public-benefit corporation that is a subsidiary of the Multidisciplinary Association for Psychedelic Studies, a 501(c)(3) non-profit organization.