SAN JOSE, Calif. - A San Jose-based medical company has submitted an application to begin providing patients with midomafetamine (MDMA) capsules paired with talk therapy for the treatment of post-traumatic stress disorder, according to a press release.
The application was submitted by the Multidisciplinary Association for Psychadelic Studies (MAPS) to the U.S. Food and Drug Administration. If the application is accepted, this would be the first psychadelic-assisted therapy in the U.S.
Now, the FDA has 60 days to determine if the new drug application will be accepted for review. If it is accepted for review, it'll be another 6-10 months for the review to be completed.
If the review is successful, and the new drug application is accepted by the FDA, the U.S. Drug Enforcement Agency would be required to reschedule MDMA and make it available for prescription use.
The application that MAPS submitted to the FDA included results of two randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of MDMA-assisted therapy.
"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. "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."
At this time, no regulatory agency has approved MDMA-asssisted therapy, as the safety and efficacy has not been established for the treatment of PTSD.