FDA expands access to MDMA as therapeutic treatment for PTSDMDMA

FDA expands access to MDMA as therapeutic treatment for PTSD

The FDA has just made access to MDMA easier for patients with hard-to-treat post-traumatic stress disorder. The development comes under Expanded Access—an FDA program that allows early access to potentially beneficial investigational therapies for people facing a serious or life-threatening condition.

On January 17, The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the FDA had approved their request to enroll patients for MDMA-assisted psychotherapy. Also known as “compassionate use“, the Expanded Access program allows patients with life-threatening or serious condition—for whom available treatments have not worked or who are unable to participate in clinical trials—the opportunity to try experimental drugs not yet approved by the FDA. The protocol will allow 50 patients to be enrolled and 10 nationwide sites to administer the drug under doctor’s supervision.

Shortly after MDMA was made illegal in 1985, MAPS was founded a year later as a non-profit research and educational organization driven to support beneficial developments in psychedelic and marijuana use. Since its inception, MAPS has invested millions into clinical trials for MDMA and undertaken a $26.9 million plan to turn it into a prescription drug. Currently in the final phases of research, MAPS expects to make the prescription availability a reality by 2021.

“The resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I’ve seen in my psychiatric career. Combining the powerful effects of pharmacology with the potential depth of psychotherapy is a compelling model for harnessing advances in neuroscience and psychopharmacology without ignoring the complexity, richness and innate capacity of the human psyche”, stated MAPS’s Acting Medical Director Michael Mithoefer.


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