MDMA Is A 'Breakthrough Therapy' For PTSD, FDA Declares

By Britni de la Cretaz 09/01/17

MDMA is inching closer to becoming available for prescription use to treat PTSD.

a hand holding a pile of blue pills.

The Food and Drug Administration (FDA) announced this week that it has designated MDMA as a breakthrough therapy for the treatment of post-traumatic stress disorder (PTSD).

Drugs are granted breakthrough therapy status if there is preliminary clinical evidence indicating that the drug may have significant improvement over already existing therapies. Once a drug receives the designation, the FDA will expedite the development and review of the drug, according to the FDA’s Fact Sheet.

"For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way," Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), said in a press release. A 2012 study reported an astonishing 75% success rate in their MDMA trials with combat veterans.

MAPS completed Phase 2 trials of the treatment with 107 participants who had chronic, treatment-resistant PTSD. Participants had suffered from their PTSD symptoms for about 18 years, on average. Results of the Phase 2 trials showed that after just three sessions of MDMA-assisted therapy, 61% no longer met the diagnostic criteria for PTSD. At the 12-month follow up, 68% no longer qualified. The next step is assessing the safety and efficacy of the treatment, which is what the Phase 3 trials will do.

The Phase 2 trials showed that MDMA can reduce fear and defensiveness and increase empathy and compassion. Tony Macie, a veteran who struggled with treatment-resistant PTSD and became addicted to drugs and alcohol to cope with the symptoms, told The Fix in 2015 that MDMA treatment was a solution for him. He said he signed up for a clinical trial because he was desperate, and that his symptoms went away almost instantly.

“The other medications had numbed me down and so I never had the chance to delve into things. Whereas the MDMA made me confront myself and get to the root of the problem,” he told The Fix.

It was announced in December 2016 that MDMA-assisted therapy had been approved for final trials by the FDA, but the designation of breakthrough therapy status is what’s new, and will expedite the trials to make the treatment more widely available more quickly. MAPS, which is a non-profit that researches psychedelics, will be funding the MDMA trials.

The hope is that people suffering from PTSD will have outcomes like Macie’s. He told The Fix, “I went from being dysfunctional to starting Expert Exchange [a non-profit that helps army veterans volunteer abroad] and becoming an advocate for MDMA-Assisted Therapy in Washington, D.C... I think it has great healing potential.”

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Britni de la Cretaz is a freelance writer, baseball enthusiast, and recovered alcoholic living in Boston. Follow her on Twitter at @britnidlc.