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Maker of MDMA-assisted PTSD treatment to seek US regulatory nod - PharmaLive

Sep 15, 2023 - pharmalive.com
The Multidisciplinary Association for Psychedelic Studies (MAPS) plans to seek regulatory approval from the U.S. Food and Drug Administration for the use of MDMA, a component of the drug Ecstasy, as a treatment for post-traumatic stress disorder (PTSD). The nonprofit organization's decision is based on data from 18 clinical trials and a recent study showing that MDMA, when combined with therapy, helped 71.2% of patients no longer meet the criteria for a PTSD diagnosis.

MAPS, established in 1986, hopes that the MDMA-assisted therapy will be approved next year, potentially boosting the emerging psychedelic therapeutics industry. No psychedelic-based therapy has yet been approved in the U.S., but MAPS and other companies like Compass Pathways are researching such drugs for potential treatments for various mental health disorders.

Key takeaways:

  • The Multidisciplinary Association for Psychedelic Studies (MAPS) plans to seek regulatory approval in the U.S. for the use of MDMA as a treatment for post-traumatic stress disorder (PTSD).
  • The application to the U.S. Food and Drug Administration will be based on data from 18 mid- and late-stage clinical trials.
  • A recent study showed that MDMA coupled with therapy helped 71.2% of patients no longer qualify for a PTSD diagnosis, compared to 46.2% of patients on a placebo.
  • No psychedelic-based therapy has been approved yet in the U.S., but MAPS and other companies are testing such drugs for potential mental health treatments.
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