MDMA-Assisted Psychotherapy Granted Expanded Access Program by FDA

50 patients will receive MDMA-assisted psychotherapy as part of an Expanded Access protocol.

The Multidisciplinary Association for Psychedelic Research (MAPS) has announced a milestone in their push to legitimize MDMA as a clinical treatment for post-traumatic stress disorder (PTSD). MDMA-assisted psychotherapy has been granted an Expanded Access program by the Food and Drug Administration (FDA).

As part of the program, 50 patients who suffer from treatment-resistant PTSD will receive the treatment at up to 10 qualified sites. MAPS plans to submit data from the first 35 patients to the FDA in hopes of convincing the U.S. federal agency to expand the program further.

“We commend FDA for recognizing the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD,” wrote MAPS Founder and Executive Director Rick Doblin, Ph.D in a statement. “We are delighted to begin generating real-world evidence about this potential new treatment.”

MDMA was designated a Schedule I controlled substance in the U.S. in 1985, meaning that it was determined to have a high potential for abuse and no accepted medical use. MAPS was founded the following year. The organization advocates for research and education that benefits individuals who might benefit from treatments involving entheogens and other psychedelics. To date, they've raised over $70 million to that end.

By 2021, MAPS expects to make MDMA available by prescription for sufferers of treatment-resistant PTSD.

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source https://edm.com/news/mdma-expanded-access-maps-fda

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