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MAPS Is Leading The Pack In MDMA Assisted Psychotherapy For The Treatment of PTSD

Jun 8, 2020 • 5:06 PM EDT
4 MIN READ  •  By Michael Berger
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So far this year, the psychedelic therapy market has been generating significant traction and this is a vertical that our readers need to be aware of. Today, we want to highlight a leading non-profit company that is focused on this vertical and believe that our readers should be aware of it.

Multidisciplinary Association for Psychedelic Studies (MAPS) was founded in 1986 and is a leading 501(c)(3) non-profit research and educational organization that is focused on developing medical, legal, and cultural contexts for the use of psychedelics and cannabis.

Since inception, MAPS has invested more than $46 million to improve education and to conduct extensive research in psychedelic therapy areas that include: MDMA-assisted psychotherapy, LSD-assisted psychotherapy, ibogaine-assisted treatment and ayahuasca-assisted therapy, among others.

MAPS: An Accelerated Psychedelics Play

When compared to other companies that are focused on the development of psychedelic therapies, MAPS represents the most advanced opportunity. The company is currently sponsoring a Phase 3 trial of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD). This is the world’s most advanced psychedelic program and is one of only three programs to be granted the breakthrough therapy designation (BTD) by the Food and Drug Administration (FDA).

Last month, MAPS reported a major milestone announcing the results of an interim analysis of the data from the first of its two Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. This suggests that MAPS’ research program is on track for approval by the FDA and we are favorable on this development.

The analysis was conducted by an independent committee and showed a 90% or greater probability that the trial will detect statistically significant results when all participants have been treated. The analysis also showed that the trial will not require additional participants beyond the first 100 and was approved by the FDA as part of MAPS’ Statistical Analysis Plan.

An Execution and Growth Story

According to MAPS Founder and Executive Director Rick Doblin, Ph.D., the results of the interim analysis is the most powerful evidence to date in regard to a MDMA-assisted psychotherapy that could help people who suffer from PTSD. MAPS has trained approx. 70 new therapists to work on the Phase 3 study. By increasing the size of the study, the results could show that the treatment is scalable, and this would prove to be a catalyst for the entire sector.

The results suggest that the FDA made the correct decision to grant MAPS the BTD for the MDMA-assisted psychotherapy for PTSD, which accelerates the clinical trial process and acknowledges MDMA-assisted psychotherapy as a potentially significant advance over the existing treatments for PTSD. The results also suggest that the expanded access designation will allow some patients early access to MDMA-assisted psychotherapy for PTSD prior to approval.

Going forward, MAPS is continuing its Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD at 15 sites in the US, 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.

To complete this research and make MDMA a legal medicine, MAPS and the Psychedelic Science Funders Collaborative (PSFC) have launched the $30 million Capstone Fund. The fund has already secured the initial $12 million and has brought together a diverse group of supporters that are committed to helping those who suffer from PTSD.

A Burgeoning Industry to be Following

The approval of an MDMA-assisted psychotherapy would be proven to be a major catalyst for the entire industry and could result in a trend that brings psychedelic medicine into the mainstream. We are bullish on the growth prospects that are associated with MAPS’ growth strategy and are favorable on the advancements that have been made on the biotech side of the business.

MAPS is focused on becoming a leader in the psychedelic therapy market and we believe that it has a great opportunity to accomplish this. So far, the company has been nothing short of an execution story and is a well-capitalized opportunity. Millions of people across the globe suffer from PTSD. We expect COVID to cause a substantial spike in the number of people who suffer from this PTSD and are favorable on the work that MAPS is doing.

If you are interested in learning more about MAPS, please send an email to or to be added to our distribution list.

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Authored By

Michael Berger


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