MAPS Completes Second Phase 3 Trial Of MDMA-Assisted Therapy For PTSD, Topline Data & New Drug Application Next

MAPS Public Benefit Corporation (PBC) announced the final participant’s last Evaluation and Exit Planning therapeutic session was completed in MAPP2, a multi-site Phase 3 study of MDMA-assisted therapy for the treatment of Post-Traumatic Stress Disorder (PTSD.)

A wholly-owned subsidiary of the renowned Multidisciplinary Association for Psychedelic Studies, MAPS PBC was founded in 2014 as a non-profit organization with the goal of developing and commercializing prescription psychedelics following a public benefit focus.

The clinical trials program for MDMA-assisted therapy (MDMA-AT) for PTSD has been sponsored by MAPS since 2000 and administered by MAPS PBC since 2014. 

Following the FDA’s designation of the treatment as a ”breakthrough therapy” in 2017, MAPS applied for and received Special Protocol Assessment (SPA) for further guidance on trial size and design. 

The SPA commits the FDA to approve the treatment provided two Phase 3 studies obtain statistical significance, with no identified new safety issues and proper gathering of data.

The results of the first Phase 3 trial were statistically significant, with a large effect size and a favorable safety profile. Specifically, MAPP1 proved that 88% of participants who received MDMA-assisted therapy had a clinically significant improvement in their PTSD symptoms, and 67% no longer qualified for a PTSD diagnosis.

Now, a blinded interim analysis of MAPP2 results conducted by an independent Data Monitoring Committee stated that, as of May 2022, the trial had a sufficient number of participants to statistically detect the efficacy of MDMA-assisted therapy for PTSD.

Both Phase 3 trials examined the safety and efficacy of MDMA-AT versus therapy with placebo control in treating individuals with PTSD, the first involving severe PTSD and the second including moderate PTSD volunteers as well. 

Yet MAPP2 presented a noticeable add-on: enrollment of people of color doubled with the total number of participants of color, representing more than 50% of the total in the study.

The organization announced that carefully considered interventions increased ethnoracial diversity among participants in the trial, providing a successful framework to address health inequalities in psychedelic science.

“The completion of data gathering in our second Phase 3 study of MDMA-assisted therapy for PTSD is a critical milestone in MAPS’ 36-year campaign to obtain FDA approval for the therapeutic use of MDMA. I’m proud of our team of therapists, staff, donors, funders, and especially the brave patients who volunteered to confront their trauma in our studies” said Rick Doblin, Ph.D., MAPS executive director. 

On behalf of MAPS PBC, CEO Amy Emerson said the completion of this confirmatory Phase 3 clinical trial is one step closer to potentially delivering MDMA-assisted therapy to the millions of Americans with PTSD who are grossly underserved.

"This has been a decades-long journey born out of a desire to explore the potential of MDMA-assisted therapy to treat various mental health conditions. Our progress to date would not be possible without the tireless commitment of the investigators, therapists, clinical trial participants and of course MAPS and the thousands of donors who have funded our research to date," said Emerson

Topline results from this second Phase 3 clinical study are expected in the first quarter of 2023, and together with the first Phase 3 trial will be the basis for the New Drug Application (NDA) to be submitted to the FDA in the third quarter of 2023.

Photo courtesy of Yuriy Golub and Bacsica on Shutterstock.