The Food and Drug Administration this month granted breakthrough designation to a Santa Cruz, Calif.-based nonprofit's MDMA therapy for post-traumatic stress disorder.
Here are five things to know.
1. Multidisciplinary Association for Psychedelic Studies is the nonprofit research group developing the MDMA-assisted psychotherapy treatment for PTSD. MDMA is a psychedelic compound that serves as the primary ingredient in the party drugs ecstasy and molly.
2. The FDA's breakthrough therapy designation program is intended to accelerate the development and review of an experimental treatment for a serious or life threatening condition when early clinical evidence shows potential for substantial improvement over existing treatment methods.
3. MAPS' MDMA therapy has already displayed promising results. In previous trials with 107 patients monitored by the FDA, 61 percent experienced significant reductions in PTSD symptoms two months after receiving three sessions of the MDMA-assisted psychotherapy. One year later, researchers found 68 percent no longer had PTSD.
4. The FDA gave MAPS permission to conduct large-scale, Phase 3 clinical trials of the therapy last November. Successful results in the late-stage trials could bring the drug one step closer to potentially being approved as a prescription drug.
"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," said Rick Doblin, MAPS' founder and executive director.
5. The stigma associated with MDMA, and the nonprofit's stated goal of making illegal drugs more mainstream, has kept some military and government leaders from endorsing the substance as a potential PTSD treatment. Others think the immediacy of the PTSD problem among soldiers supersedes these concerns, according to The Washington Post.
"We're in this odd situation where one of the most promising therapies also happens to be a Schedule 1 substance banned by the [Drug Enforcement Administration]," retired Brig. Gen. Loree Sutton, who was the highest-ranking psychiatrist in the U.S. Army until 2010, told the Post. "If this is something that could really save lives, we need to run and not walk toward it. We need to follow the data."
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