FDA Approves Phase III Clinical Trials for MDMA in Treatment of PTSD


MDMA PTSD Treatment

The US Food and Drug Administration (FDA) concluded phase II trials of MDMA (aka Ecstasy or Molly) in November, 2016, and the drug has now been approved for phase III testing in the treatment of acute post traumatic stress disorder (PTSD). Although there is strong consideration for the legalization of medical MDMA, the prescription process would be far more restrictive when compared to other prescription narcotics. In limited trials, patients suffered from PTSD received a dose of MDMA in a controlled environment and then participated in extensive talk-therapy. According to the resolved research, more than two-thirds of patients who participated in phase II trials have sustained remission of PTSD symptoms.

A total of 80 licensed therapists have been tasked with participating in the FDA’s phase III testing. Of those is NYU’s director of addiction medicine, Stephen Ross. Ross has setup what he calls a “dosing room” in which he administers MDMA to patients and then engages them with talk-therapy for 8 consecutive hours. If the FDA ultimately approves MDMA for medicinal use, it will only be available in a residential program. It will not be available through a pharmacy with a prescription.