MAPS Clinical Plan for End-of-Phase 2 Meeting with the U.S. FDA to Develop MDMA as a Prescription Medicine for PTSD

On Monday, March 22, MAPS received final approval from our Institutional Review Board (IRB) to move forward with our new MDMA/PTSD study. Michael Mithoefer, M.D. and Annie Mithoefer, BSN will conduct this new study in Charleston, South Carolina. They both ran the previous MAPS-sponsored US MDMA/PTSD study, which successfully demonstrated both safety and efficacy in treating treatment-resistant PTSD patients with MDMA-assisted psychotherapy and produced statistically and clinically significant findings. A scientific paper about the results is currently being evaluated for publication by a journal.

In the Mithoefers previous study of 21 people suffering from treatment-resistant PTSD, only two of the subjects were military veterans, and all but three of the subjects were women who were survivors of sexual assault or childhood sexual abuse. This new study will be conducted entirely with U.S. war veterans with PTSD. This study will help us determine if our treatment can be applied to people with PTSD from different causes or if our treatment itself needs to be modified to match the cause of the PTSD. Unlike the Mithoefers first study, which only had two groups (inactive placebo and full-dose MDMA), this study will compare three doses of MDMA—30 mg, 75 mg, and 125 mg, in an effort to enhance the double-blind. Most importantly, we will be testing what may become the protocol design that will be used in our large-scale, multi-site Phase 3 studies.

Because the Mithoefers previous study was the first study of its kind, we needed to establish a baseline of potential side effects of psychotherapy alone in people with PTSD who were treated with a placebo. People who received nothing but a placebo still reported side effects, so it was important that we have a pure placebo control, otherwise any of these side effects could be attributed to the MDMA. The rightful criticism of our first study, and the primary critique of the data so far, has been that it wasnt effectively double-blind because the subjects could easily tell if they were given the active drug or a placebo. That criticism will be addressed in the Mithoefers new study, and an active placebo of low-dose MDMA is being used in our other studies abroad—in Israel, Switzerland, Canada, Spain, and Jordan.

The Mithoefers new study will be a methodological response to the primary critique of our first study. In addition to our research in the United States, MAPS is currently engaged in MDMA/PTSD studies in several other countries around the world—Switzerland, Israel, and soon Canada, Jordan, and Spain. All of these studies are intended to prepare us for an End-of-Phase 2 meeting with the FDA, the purpose of which is to come to agreement with the FDA on the design of the large-scale Phase 3 studies that we want to conduct. At the meeting, we will review our data, and explain the methodological and statistical considerations in our proposed design of a large-scale, multi-site, Phase 3 safety and efficacy trial. Once weve come to an agreement on the design of our Phase 3 studies, if we get good results and show safety and efficacy, then the FDA will approve our application to market MDMA for PTSD patients.

The Mithoefers new study in veterans has been approved by both the FDA and the IRB, so now were waiting for the DEA to facilitate the licensing and transfer of the MDMA so we can begin this study. Michael and Annie Mithoefer will be giving a presentation about their work at the upcoming MAPS-sponsored Psychedelic Science conference in San Jose next month, and their workshop about MDMA and PTSD is already almost filled to capacity.