On October 12, 2016, the U.S. Food and Drug Administration (FDA) confirmed their receipt of MAPS’ materials in support of our End of Phase 2 meeting with the FDA, scheduled for November 29, 2016. The submission included a 90-page summary of initial indications of safety and efficacy based on our Phase 2 results, plus what is now known about the toxicology, pharmacology, and abuse liability of MDMA from over 5000 peer-reviewed scientific papers published on MDMA or Ecstasy. We also had multiple attachments consisting of our Chemistry, Manufacturing, and Control (CMC) proposal for MDMA production under current Good Manufacturing Practice (cGMP) standards for Phase 3 and post-approval formulation, toxicological study proposals, key elements of MDMA-assisted psychotherapy, and key references. The goal of our End of Phase 2 Meeting will be to come to an agreement on the design of our upcoming Phase 3 trials, the final stage of research required to gather evidence proving safety and efficacy sufficient for FDA to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD. Learn more…
