Thanks to the promising results of a groundbreaking new study, advocates for the implementation of MDMA-assisted PTSD therapy are hopeful that FDA approval could be possible by 2023.
The Multidisciplinary Association for Psychedelic Studies (MAPS) announced this week the results of the first Phase 3 trial for MDMA-assisted therapy for PTSD, noting that the latest findings expand on the positive outcomes shown in its previously released Phase 2 results.
The Phase 3 trial was designed under the FDA’s Special Protocol Assessment guidelines and included 90 patients who all suffered from “severe, chronic” PTSD. Participants were randomized to receive a trio of sessions of either MDMA or a placebo alongside, both alongside talk therapy.
Among those who received MDMA-assisted therapy, 67 percent were said to no longer qualify for a PTSD diagnosis after three sessions. 88 percent of participants, meanwhile, saw a “clinically significant” reduction in PTSD symptoms.
The lead author of a forthcoming paper on these results—Jennifer Mitchell, Ph.D.—explained in a press release just how integral the latest findings are to the community of researchers working toward viable, modern treatment methods. Mitchell also pointed to MDMA’s signature capability of getting patients across significant hurdles with regards to addressing trauma from one’s post.
“While many forms of PTSD therapy involve recalling previous trauma, the unique ability of MDMA to raise compassion and understanding while tamping down fear is likely what enables it to be so effective,” Mitchell said.
As expected, no serious safety issues were detected among the Phase 3 trial participants. More specifically, any less-than-desirable effects of the treatment—i.e. sweating, decreased appetite, etc.—were (of course!) temporary.
Next up, with the goal of a widened 2023 approval firmly in mind, a second Phase 3 clinical trial will begin soon. MAPS is currently enrolling participants for that study. Additionally, MAPS is planning to conduct more studies aimed at showing MDMA-assisted therapy’s potential as a treatment option for other mental health conditions.
Nature Medicine will publish a peer-reviewed paper on the first Phase 3 trial’s findings soon. The study itself, sponsored by MAPS and conducted by the MAPS Public Benefit Corporation, was recently featured in a New York Timesreport ahead of that paper’s release.
All told, this is excellent news for the future of increased therapy options. These latest findings also further bolster the broader argument surrounding the need for all so-called drugs to be decriminalized.
