MAPS Completes Second Phase 3 Trial of MDMA-Assisted Therapy for PTSD, Key Data and New Drug Application

MAPS Public Benefit Corporation (PBC) announced that the final therapeutic participant assessment and discharge planning session has been completed as part of MAPP2, a multi-site phase study 3 on 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 psychedelics by order in the public interest. .

The clinical trial 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 designation of the treatment as a "Breakthrough Therapy" in 2017, MAPS requested and received a Special Protocol Assessment (SPA) for additional advice on sizing and trial design.

SPA urges FDA to approve treatment provided two Phase 3 studies achieve statistical significance, no new safety issues identified, and proper data collection.

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

Now a blinded interim analysis of MAPP2 results conducted by an independent data monitoring board said that as of May 2022, the trial had sufficient numbers of participants to statistically detect the effectiveness of MDMA-assisted therapy for PTSD.

The two phase 3 trials examined the safety and efficacy of MDMA-AT versus placebo-controlled therapy in treating people with PTSD, the first involving severe PTSD and the second including volunteers with moderate PTSD as well.

Yet MAPP2 had a notable addition: enrollment of people of color doubled with the total number of participants of color, accounting for over 50% of the study total .

The organization announced that carefully studied interventions increased ethno-racial diversity among trial participants, providing an effective framework to address health inequities in psychedelic science.

"The completion of data collection in our second Phase 3 study of MDMA-assisted therapy for PTSD is a critical milestone in MAPS's 36-year campaign to obtain FDA approval for the therapeutic use of MDMA. I am 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. executive director of MAPS.

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 MAPS-assisted therapy. MDMA to the millions of Americans with PTSD who are severely underserved.

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

The first results of this second phase 3 clinical study are expected in the first quarter of 2023, and with the first phase 3 trial with...