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    FDA to Consider Reviewing MDMA Plus Therapy to Treat PTSD

    The Food and Drug Administration (FDA) this week was asked to review the psychoactive substance MDMA along with therapy as a treatment for post-traumatic stress disorder (PTSD). If approved, it would be the first psychedelic-assisted therapy approved for PTSD.

    The application was filed by a company called the MAPS Public Benefit Corporation, CNN reports. The FDA has 60 days to decide whether to accept the new drug application for review, and whether to fast-track it through the approval process.

    In 2017 the FDA granted MDMA-assisted therapy a breakthrough therapy designation. This status speeds up the development and review of medications that are meant to treat a serious condition, and that preliminary clinical evidence suggests may be a substantial improvement over available treatments.

    Two studies found that MDMA significantly reduced symptoms and impairment associated with PTSD compared with a placebo. The article notes that some people do not respond to current treatments for PTSD, including antidepressants and some specialized types of cognitive behavioral therapy.

    MDMA is currently a Schedule I drug under the Controlled Substances Act, which the Drug Enforcement Administration defines as having no currently accepted medical use. If the FDA approves MDMA as a treatment for PTSD, the substance would need to be rescheduled.


    December 2023