Submission of New Drug Application to the U.S. FDA for MDMA-Assisted Therapy for PTSD

A New Drug Application (NDA) for MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) has been submitted to the U.S. Food and Drug Administration (FDA) by MAPS PBC, a clinical stage company. MDMA is intended to be used in conjunction with psychological interventions such as psychotherapy or talk therapy.

This submission represents the first psychedelic-assisted therapy to be considered for FDA approval.

Amy Emerson, CEO of MAPS PBC said: “The filing of our NDA is the culmination of over 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new treatment option to adults living with PTSD, a patient group that has seen little innovation in decades.” She added: “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, potentially catalyzing further investment in mental health research.”

The NDA includes data from numerous studies, notably two randomized, double-blind, placebo-controlled Phase 3 studies. Both studies achieved their primary and secondary endpoints and were published in Nature Medicine.

In 2019, MDMA-assisted therapy was granted Breakthrough Therapy Designation. MAPS PBC also agreed on a Special Protocol Assessment regarding study design. In 2021, the FDA began a rolling review of portions of MAPS PBC’s research. These developments enhance the probability of FDA approval, which could occur in the second half of 2024.

PTSD affects 8 million Europeans.  

For more information, including what is PTSD, what is MDMA, and what is the MDMA-assisted therapy, visit the official MAPS announcement.