Core Insights - PharmAla Biotech Holdings Inc. has entered into an agreement with Spaulding Rehabilitation to provide LaNeo™ MDMA for a clinical trial focused on MDMA-assisted therapy for fibromyalgia [1][2] Company Overview - PharmAla Biotech is a biotechnology company specializing in the research, development, and manufacturing of MDXX class molecules, including MDMA [8] - The company aims to alleviate the backlog of generic, clinical-grade MDMA for clinical trials and commercial sales, while also developing novel drugs in the same class [8] - PharmAla is currently the only provider of clinical-grade MDMA for patient treatments outside of clinical trials [8] Clinical Trial Details - The clinical trial, titled "Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-Assisted Therapy in Fibromyalgia," will be led by Dr. Vitaly Napadow at Spaulding Rehabilitation [2][3] - The study will utilize advanced hyperscan neuroimaging techniques to explore the brain mechanisms involved in pain relief from MDMA-assisted therapy, marking a new application of MDMA beyond PTSD treatment [3][4] Research Collaboration - Under the agreement, PharmAla will provide LaNeo™ MDMA at no cost, in exchange for a license to the study results [2][5] - Spaulding Rehabilitation will deliver comprehensive study results to PharmAla within 90 days of study completion, including group means and regression analysis plots [5] - PharmAla will leverage the findings for potential regulatory submissions, while Spaulding retains the right of first publication in a peer-reviewed journal [5]