FDA moves one step closer to approving medical ecstasy

On Tuesday, the Food and Drug Administration gave the green light to a small nonprofit research group in Santa Cruz, Calif., to conduct large-scale, Phase 3 clinical trials of MDMA to treat post traumatic stress disorder, reports The New York Times.

 Successful results in the late-stage trials could bring MDMA, or ecstasy, one step closer to potentially being approved as a prescription drug.

The Multidisciplinary Association for Psychedelic Studies previously sponsored six Phase 2 studies of the drug involving 130 PTSD patients. In one of the studies, researchers found patients who received three doses of MDMA — administered under a psychiatrist's guidance — recorded a 56 percent decrease in the severity of their symptoms on average, according to the report.By the end of the study, two-thirds of the participants no longer met the criteria for having PTSD.

MAPS will also fund Phase 3 research, which will include at least 230 patients, the New York Times reports. Researchers applied for breakthrough therapy status through the FDA, which could speed up the regulatory process and make the drug available by 2021, if approved.

“I’m cautious but hopeful,” said Charles R. Marmar, MD, head of psychiatry at New York University’s Langone School of Medicine, who was not involved in the study, according to the report. “If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30 to 40 percent of people. So we need more options.”

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