In big industry news, MAPS has published the second part of its long-awaited Phase 3 trial of MDMA-assisted therapy for PTSD.
The first part of the Phase 3 trial had potentially historically significant results, and the entire industry has been waiting for the second part of its Phase 3 study. A successful outcome in this confirmatory Phase 3 trial would set the stage for a likely FDA approval of MDMA for PTSD.
Results of the second Phase 3 trial have now been published in Nature Medicine, showing details of MDMA-assisted therapy for posttraumatic stress disorder.
Some highlights:
- “…45 of 52 (86.5%) participants treated with MDMA-AT achieved a clinically meaningful benefit, and 37 of 52 (71.2%) participants no longer met criteria for PTSD”
- The MDMA group achieved remission of PTSD at more than double the rate of the placebo group (reduction in CAPS-5 score was 23.7 in MDMA group vs 14.8 for placebo group, both with therapy).
- Five participants in the MDMA-AT group had severe adverse effects (9.4%) versus two in the placebo group.
These results seem to confirm the impressive results from both MAPS’ Phase 2 and previous Phase 3 studies.
According to the press release, MAPS PBC is now compiling data from 18 MAPS-sponsored Phase 2 and Phase 3 studies to form the basis of the New Drug Application, expected to be filed with the FDA later this year.
Stay tuned to Microdose for more on this historic step for psychedelic medicine.
