- An independent Data Monitoring Committee has reviewed data from MAPS’ ongoing Phase 3 clinical trial
- The results are the strongest confirmation that an interim analysis can provide
- MAPS and the Psychedelic Science Funders Collaborative have launched the Capstone Fund to raise the $30 million needed to complete the research and make MDMA a medicine
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.”
MAPS is continuing its Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD at 15 sites in the U.S., Canada, and Israel. The Phase 3 trials are expected to be completed in 2021, meaning that the FDA could approve the treatment as early as 2022. MAPS is also in the process of obtaining regulatory approvals for Phase 2 trials in the UK, Germany, Czech Republic, and the Netherlands.
PTSD affects millions—and soon to be millions more—due to the global trauma of the COVID-19 pandemic. This includes victims of the disease and their families, health care and emergency service professionals, as well as front-line workers who are risking their lives to provide essential services.
As a non-profit organization focused on mental health services, MAPS is committed to protecting the safety of its study staff and clinical trial participants. MAPS is taking active measures to minimize the risk of exposure to the COVID-19 virus and adhere to physical distancing. As a result of this initiative, new enrollment of participants in MAPS-sponsored trials is temporarily postponed, with treatments continuing for some participants as evaluated on a case-by-case basis.
“I believe this medication-assisted treatment will be a breakthrough in treating trauma,” says Amy Emerson, Executive Director of MAPS Public Benefit Corporation (MAPS PBC). “I would like to thank the investigators leading the studies, study volunteers for their time and participation, the independent Data Review Committee for their careful analysis, and the amazing research team at MAPS PBC who helped us achieve this milestone in non-profit pharmaceutical development.”
About MDMA-Assisted Therapy for PTSD
MDMA-assisted psychotherapy uses MDMA to improve the effectiveness of psychotherapy for PTSD. The treatment involves up to three administrations of MDMA in conjunction with psychotherapy in a controlled clinical setting as part of a course of psychotherapy. Once approved, patients will not be able to take the MDMA home—patients won’t be filling their prescriptions at their local pharmacy. Instead, MDMA-assisted psychotherapy treatment will only be available through a doctor and only in supervised therapeutic settings from certified clinicians.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $80 million for psychedelic therapy and medical marijuana research and education. For more information, visit maps.org.
MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MAPS PBC), a wholly owned subsidiary of MAPS formed in 2014 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. For more information, visit mapsbcorp.com.
Psychedelic Science Funders Collaborative (PSFC) is a community of philanthropists dedicated to supporting psychedelic medicine. A 501(c)(3) nonprofit, PSFC supports research on and clinical trials of physician-prescribed psychedelic medicines and patient access to these treatments. PSFC was founded in 2017 out of a realization that psychedelic medicine has the potential to make an enormous impact and has an achievable path to regulatory approval, but has been systemically underfunded. For more information, visit psfc.co.