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).
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.