Public benefit corporation submits NDA to FDA for MDMA-assisted therapy to treat PTSD

A public benefit corporation that develops psychedelic therapies has submitted a new drug application to the FDA this week to use MDMA combined with psychotherapy to treat PTSD, according to a press release.

“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,” Amy Emerson, BS, CEO of MAPS Public Benefit Corporation, said in the release. “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 used data from two phase 3 trials that studied the safety and efficacy of MDMA-assisted therapy vs. placebo for individuals with moderate to severe PTSD. Both studies met their primary and secondary endpoints, and no serious adverse events were reported in either study.

MDMA was designated as a breakthrough therapy in 2017. If the NDA is approved, the U.S. Drug Enforcement Administration will schedule MDMA to make it available for medical use with a prescription.