Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced the results of an interim analysis of the data from the first of its two Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). This is the best-case scenario for an interim analysis, and suggests that MAPS’ research program is on track for approval by the U.S. Food and Drug Administration (FDA).
The analysis was conducted by an independent Data Monitoring Committee, which reviewed the results from the first 60 out of 100 participants. The analysis revealed a 90% or greater probability that the trial will detect statistically significant results when all participants have been treated, and that the trial will not require additional participants beyond the first 100. The interim analysis was approved by the FDA as part of MAPS’ Statistical Analysis Plan approved by the FDA.
The results strongly suggest that the FDA made the right decision in granting MAPS both (1) Breakthrough Therapy Designation for MDMA-assisted psychotherapy for PTSD, which accelerates the clinical trial process and acknowledges MDMA-assisted psychotherapy as a potentially significant advance over currently available treatments for PTSD, and (2) Expanded Access, which will allow some patients early access to MDMA-assisted psychotherapy for PTSD prior to approval.
Not all interim analyses are successful. For example, in February 2020, Tonix Pharmaceuticals’ Tonmya®, the only other drug granted Breakthrough Therapy Designation by the FDA for PTSD, failed its interim analysis.
“In the pharmaceutical drug development community, this is what you dream about,” says Rick Doblin, Ph.D., MAPS Founder and Executive Director. “The results of the interim analysis of MAPS’ pivotal first Phase 3 trial are the most powerful evidence yet that MDMA-assisted psychotherapy could help transform the lives of people suffering from PTSD. We have trained approximately 70 new therapists to work on Phase 3, so these results also show that the treatment is scalable, eventually to tens of thousands of therapists worldwide.”
To complete this research and make MDMA a legal medicine, MAPS, in collaboration with the Psychedelic Science Funders Collaborative (PSFC), has launched the $30 million Capstone Fund. The Capstone Fund has already secured the first $12 million, and has brought together a diverse array of supporters committed to healing PTSD globally.
“Psychedelic medicines show incredible promise for treating a range of mental health conditions, but psychedelic research has been underfunded for decades,” says Joe Green, Co-Founder and President of PSFC. “This first look at data from the first-ever Phase 3 trial of a psychedelic-assisted therapy only makes us more confident that we’re standing on the cusp of a breakthrough. The approval of MDMA-assisted psychotherapy would be a catalytic event that brings psychedelic medicine into the mainstream. That’s why we are excited to partner with MAPS in creating the Capstone Fund to bring this research across the finish line.”