Tonix Pharmaceuticals announced a poster presentation at ISPOR 2026 on May 17-20 in Philadelphia analyzing fibromyalgia patients in the United States. The retrospective cohort study analyzed U.S. claims data from April 2021 to April 2024 for adults with fibromyalgia, presented by William Olsufka, PharmD, of Tonix Medicines, Inc., in session 5 on Wednesday, May 20, 2026, from 9:00 to 11:30 a.m. ET.
Fibromyalgia is a chronic pain disorder affecting more than 10 million adults in the United States, with approximately 90% being women. The condition results from amplified sensory and pain signaling within the central nervous system and presents with chronic widespread pain, nonrestorative sleep, fatigue, morning stiffness, cognitive dysfunction, and mood disturbances including anxiety and depression. TONMYA (cyclobenzaprine HCl sublingual tablets 2.8 mg) was approved by the U.S. FDA on August 15, 2025, and commercially launched on November 17, 2025, representing the first new prescription medicine approved for fibromyalgia in more than 15 years.
TONMYA is a patented sublingual tablet formulation providing rapid transmucosal absorption while reducing production of norcyclobenzaprine, a long half-life active metabolite, through bypass of first-pass hepatic metabolism. The drug acts as a multifunctional agent with potent binding and antagonist activities at multiple receptor systems. The most common adverse reactions with incidence at or above 2% include oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
U.S. Patent and Trademark Office patents issued in May 2017, May 2018, November 2018, July 2019, and August 2020 are expected to provide TONMYA with U.S. market exclusivity until 2034/2035. Tonix is also investigating TONMYA in Phase 2 clinical trials for major depressive disorder and acute stress disorder/acute stress reaction.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/tonix-pharmaceuticals-to-present-retrospective-u-s-real-world-claims-analysis-characterizing-patients-with-fibromyalgia-at-ispor-2026