PharmAla Signs Drug Donation Agreement for MDMA-Assisted Therapy Clinical Trial in Fibromyalgia

Executive Summary

• PharmAla Biotech Holdings entered into a collaboration agreement with Spaulding Rehabilitation (Mass General Brigham) to supply LaNeo™ MDMA at no charge for a clinical trial investigating MDMA‑assisted therapy for fibromyalgia.
• The study will use hyperscan neuroimaging to explore brain mechanisms of analgesia, and PharmAla will receive a license to the study results for potential regulatory submissions and other public applications.
• Intellectual property rights are split: PharmAla retains rights to innovations related to the drug; Spaulding retains rights to discoveries made independently by its research team, with a right of first publication in a peer‑reviewed journal.

Key Details

• Agreement Scope: Supply of clinical‑grade LaNeo™ MDMA (MDXX class) at no charge to Spaulding Rehabilitation for the trial titled “Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA‑Assisted Therapy in Fibromyalgia.”
• Study Leadership: Principal Investigator Vitaly Napadow, PhD (Spaulding Rehabilitation); Co‑Investigator Franklin King, MD (Massachusetts General Hospital).
• Therapeutic Focus: Fibromyalgia – an estimated 4 million U.S. adults suffer from this chronic pain condition; the trial explores a novel indication beyond PTSD for MDMA‑assisted therapy.
• Data Rights & Use: Spaulding will deliver comprehensive results (group means, pre/post analyses, regression plots) within 90 days of study completion. PharmAla may leverage findings for regulatory filings and broader public applications; Spaulding retains first right to publish.
• Intellectual Property Allocation:
• PharmAla – rights to innovations directly related to LaNeo™ MDMA and its use in the study.
• Spaulding – rights to independently generated discoveries by its research team.
• Potential Impact: Positive clinical data could support future regulatory submissions for MDMA‑based analgesic therapies, expanding PharmAla’s pipeline beyond PTSD.
• Access Information: Researchers can request LaNeo™ MDMA for trials via https://pharmala.ca/clinical-trials, which includes product quality documentation.

Notable Quotes

• “This agreement marks an important expansion of the clinical research into LaNeo™ MDMA beyond PTSD and into new therapeutic indications,” – Nicholas Kadysh, CEO, PharmAla Biotech.
• “Fibromyalgia is a condition in which subjective pain, brain circuitry, and interpersonal context are tightly intertwined… our aim is to better understand the neural mechanisms that support meaningful pain relief,” – Vitaly Napadow, PhD, Principal Investigator.

Materiality Assessment: Material – Positive (the collaboration introduces a new therapeutic indication for PharmAla’s flagship MDMA product and could generate data pivotal for future regulatory approvals.)