Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Publication in Nature Medicine and Major Media Coverage

On May 3, 2021, we announced that the first Phase 3 trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD) which replicated and expanded on Phase 2 results indicates that MDMA-assisted therapy may be an effective and cost-saving treatment for PTSD. On May 10, Nature Medicine published the peer-reviewed paper detailing the results of the study. In this first Phase 3 trial of any psychedelic-assisted therapy, participants who received MDMA-assisted therapy reported a significant reduction in PTSD symptoms compared to those who received placebo with therapy (p<0.0001), successfully achieving the prespecified primary endpoint for the trial. In fact, 67% of the group who received MDMA, compared to 32% of the group who received placebo, no longer qualified for a PTSD diagnosis after three treatment sessions. In addition, participants treated with MDMA-assisted therapy had statistically significant reductions for the key secondary endpoint of functional impairment relative to placebo with therapy (p=0.0116). Read the full press release here.

This exciting accomplishment led to news coverage by major media outlets. Articles about the Nature Medicine publication appeared in The New York Times, BBC, Scientific American, Newsweek, CNBC, and more.