Company Seeks FDA Approval for MDMA as Treatment for PTSD

WEDNESDAY, Dec. 13, 2023 (HealthDay News) -- A California company is asking the U.S. Food and Drug Administration to consider approving MDMA (midomafetamine capsules) as a treatment for posttraumatic stress disorder (PTSD).

When announcing the new drug application (NDA) filing on Tuesday, MAPS Public Benefit Corp. noted it has been studying the drug for this use for years. The FDA has 60 days to decide whether MDMA will be accepted for review and whether it will be fast-tracked through the approval process, the company said. The drug would be given in concert with talk 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," MAPS CEO Amy Emerson said in a company news 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."

Back in 2017, the FDA granted MDMA-assisted therapy a breakthrough therapy designation. The MDMA application included data on two studies, with 90 and 104 participants, respectively, that showed MDMA significantly reduced symptoms and impairment associated with PTSD when compared with a placebo. MAPS added that it has now completed a total of six late-stage clinical trials testing MDMA for PTSD.

If the FDA approves MDMA for this purpose, it would need to be rescheduled, MAPS noted, because it is a schedule I drug under the Controlled Substances Act, which the U.S. Drug Enforcement Administration defines as having no accepted medical use.

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