In my talk, I’ll discuss MAPS Public Benefit Corporation’s drug development work and the alternative treatment options we are creating to address some of the most challenging mental health issues. To date, most of our work has been focused on creating a viable treatment option for posttraumatic stress disorder (PTSD), which affects millions of people every year. This condition, along with numerous other mental health disorders, lacks sufficient treatment options. 

Currently, we are in the final stages of Phase 3 clinical trials for MDMA-Assisted Therapy as a treatment for posttraumatic stress disorder (PTSD). Our study is the first Phase 3 clinical trial of any psychedelic-assisted therapy, and the results are promising: 67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis, and 88% experienced a clinically meaningful reduction in symptoms. We are hopeful our results will facilitate FDA approval for this Breakthrough-designated therapy in 2023. During the Phase 3 program, we will also begin negotiations with FDA about REMS (Risk Evaluation and Mitigation Strategies) for implementation. 

Parallel studies are beginning in Europe. We expect to expand our pipeline to include other indications and psychedelic drug applications following FDA approval. Phase 4 studies including our Hepatic Impairment Study, Relapse Treatment, Non-responders’ study, Pediatric PTSD Phase 3 studies are slotted to begin at the end of 2023 or the beginning of 2024. 

In addition to our research efforts, we are putting in motion a strategy for commercialization of MDMA-Assisted Therapy (MDMA-AT) following FDA approval. This includes scaling up our MDMA-Assisted Therapy Training Program, working with payers/insurers to establish reimbursement for MDMA-AT (both drug and therapy), and creating a therapist certification organization. The process of bringing this treatment from the research setting to patients and providers in the real world, at scale, is one of our top priorities.  

If approved, the demand for MDMA-AT will likely be great. More than 1,500 clinicians and counselors have enrolled in the program to date. Our goal is to train and certify 10,000 practitioners by 2025.