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FDA Approves Increased Access to MDMA for PTSD | Blog

Legally reviewed by Brendan Garcia , Owner and Lead Attorney

A landmark development in MDMA-assisted psychotherapy has been reached, as the U.S. Food and Drug Administration has approved the increased access to Methyl​enedioxy​methamphetamine for treating post-traumatic stress disorder (PTSD) in former servicemembers. Under the program known as Extended Access, the FDA has approved 10 sites across the country to administer the drug to an additional 50 people. This is the first-time patients outside of clinical trials will be able to access MDMA-assisted psychotherapy.

The study of MDMA has been led by the non-profit, Multidisciplinary Association for Psychedelic Studies, or MAPS, since the drug was made illegal in 1985. MDMA, commonly referred to as molly or ecstasy, is a psychedelic that boosts feelings of social connectedness, empathy, and euphoria.  The drug temporarily prohibits the brain’s ability to comprehend fear, as it is flooded with feel-good neurotransmitters, including dopamine and serotonin. This allows veterans with PTSD to process difficult memories that their brains attempt to block out due to trauma.

Since its founding, MAPS has invested $26.9 million in researching MDMA in hopes of it becoming a prescription drug. The group is currently conducting its third and final phase of clinical trials at 15 sites across the United States, Canada, and Israel. These trails are set to run until 2021, and complete market approval may come as early as 2022, pending confirmation by the FDA.

Results Thus Far

So far the study has shown positive results, with a Phase 2 trial near Charleston, South Carolina resulting in 68 percent of its participants no longer showing PTSD symptoms after only the second session.

The exact locations for the additional 10 sites to be added as part of the Expanded Access program are to be announced in the coming months, with MAPS already receiving more than 120 applications from potential sites. MAPS hopes to broaden the program once the results from the initial 50 patients proves its efficacy.

Since the treatment has not yet received approval from the FDA, former servicemembers cannot have the costs of the treatment covered by health insurance. It has been estimated that the average cost of treatment for MDMA-assisted psychotherapy is around $15,000, but MAPS is working with insurance companies to change that.

PTSD in Veterans

Veterans experience PTSD at a much higher rate than the rest of the general population. The Department of Veterans Affairs (VA) estimates that between 11 to 20 percent of veterans who have served in Iraq or Afghanistan experience PTSD, compared to seven to eight percent of the general population.

While PTSD was previously thought to be a lifelong illness, MAPS’s work on MDMA-assisted psychotherapy indicates that it may be a treatable mental illness. With few FDA-approved treatments for PTSD, new treatments are desperately needed, and MDMA might be the future of helping former servicemembers suffering from the disease. Reach out to VetLaw’s dedicated legal team for any questions you may have on these ongoing changes.