Toronto, Ontario, February 26, 2026 – PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), announced that it has executed an agreement with Spaulding Rehabilitation (“Spaulding Rehabilitation”), a member of the Mass General Brigham healthcare system, for the provision of MDMA for use in a clinical trial investigating MDMA-assisted therapy for the treatment of fibromyalgia.
Under the agreement, PharmAla will provide its LaNeo™ MDMA at no charge to Spaulding Rehabilitation for use in a study entitled “Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-Assisted Therapy in Fibromyalgia,” in exchange for a license to the study results. The study will be conducted under the direction of Principal Investigator Vitaly Napadow, PhD, of Spaulding Rehabilitation in Boston, Massachusetts.
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, and cognitive difficulties, affecting an estimated 4 million adults in the United States alone. The study will employ advanced hyperscan neuroimaging techniques to investigate the brain mechanisms underlying pain relief following MDMA-assisted therapy, representing a novel application of MDMA beyond its more widely studied use in the treatment of post-traumatic stress disorder (PTSD).
Investigator Perspectives
“Fibromyalgia is a condition in which subjective pain, brain circuitry, and interpersonal context are tightly intertwined,” said Vitaly Napadow, PhD, Principal Investigator of the study and Director of the Scott Schoen and Nancy Adams Discovery Center for Chronic Pain Recovery at Spaulding Rehabilitation. “By using hyperscan neuroimaging, this study allows us to examine how MDMA-assisted therapy may influence not only individual brain activity, but coordinated brain-to-brain dynamics that are increasingly recognized as important for therapeutic alliance, pain modulation, and analgesia. Our aim is to better understand the neural mechanisms that support meaningful pain relief, rather than focusing solely on symptom change.”
“Fibromyalgia sits at a difficult crossroads between mind and body, where neither purely biomedical nor purely psychological models are sufficient,” said Franklin King, MD, Psychiatry Lead Co-Investigator and Director of Training and Education at the Center for the Neuroscience of Psychedelics at Massachusetts General Hospital. “MDMA-assisted therapy offers a unique opportunity to engage this interface by simultaneously influencing affective, cognitive, and embodied aspects of pain. This study reflects a broader effort to explore integrated approaches for complex, treatment-resistant conditions that do not fit neatly into traditional clinical categories.”
Expanding Research Collaborations
“This agreement marks an important expansion of the clinical research into LaNeo™ MDMA beyond PTSD and into new therapeutic indications,” said Nicholas Kadysh, CEO of PharmAla Biotech. “Fibromyalgia affects millions of patients worldwide, and current treatment options are limited. We are excited to support this groundbreaking research into the potential analgesic mechanisms of MDMA-assisted therapy, and we look forward to the important data that will emerge from this study.”
As part of this collaboration, Spaulding will deliver comprehensive study results to PharmAla — including group means, pre- and post-therapy analyses, and regression analysis plots — within 90 days of the study's completion. PharmAla will have the ability to leverage these findings for a broad range of public applications, including potential regulatory submissions, while Spaulding retains the right of first publication in a peer-reviewed journal. Intellectual property arising from the study will be held by the respective parties best positioned to advance its potential, with PharmAla retaining rights to innovations directly related to the study drug, and Spaulding retaining rights to discoveries made independently by its research team.
Researchers interested in accessing LaNeo™ MDMA for clinical trials may visit https://pharmala.ca/clinical-trials for additional information, including access to drug product quality documentation.
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO
press@pharmala.ca