FDA Moves to Review MDMA for PTSD Therapy

FDA to review MDMA-assisted PTSD therapy, a milestone for psychedelics.

The Multidisciplinary Association for Psychedelic (MAPS) Corporation has applied for the approval of MDMA as an effective drug for PTSD treatment. The psychedelic drug – also known as Ecstasy – will be the first treatment of its kind to treat post-traumatic stress disorder as a therapy initiative. 

This filing has been considered a milestone in the researcher’s quest to move psychedelic drugs from tightly restricted substances to accessible medical treatments. This comes to fruition after decades of studies underlying the positive effects of psychedelics as a treatment for mental health disorders. Other known psychedelics that are used and deemed as successful remedies are psilocybin and ketamine.  

MAPS has been studying MDMA in combination with therapy to treat PTSD since 2017. The agency granted MDMA-assisted therapy as a breakthrough therapy designation, indicating that it has the power to be more effective than other available therapies at the moment.

In a news release by MAPS CEO Amy Emerson, she highlights that the filing of the application 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 has completed six late-stage clinical trials testing MDMA for PTSD. The studies show that MDMA significantly reduced symptoms and impairment associated with PTSD. Current treatments for PTSD include antidepressants and specialized forms of cognitive behavioral therapy which are considered moderately effective. 

The FDA will have 60 days to determine whether or not the application is accepted for review and fast-tracked through the approval process. If the FDA does approve MDMA as a medical treatment, the drug will be rescheduled from a Schedule 1 drug – which is currently classified as a drug with no accepted medical use.

Kathryn Allyn

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