Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented real-world data at the 2026 American Society of Clinical Psychopharmacology Annual Meeting showing that opioid use remains widespread among U.S. adults diagnosed with fibromyalgia, despite longstanding treatment guidelines discouraging their use. The findings underscore a significant gap between clinical practice and evidence-based recommendations, according to the company.
Based on a retrospective analysis of more than 261,000 patients in the Symphony Health claims database, the study found that approximately 40% of commercially insured, Medicare Advantage and Medicaid patients with fibromyalgia were prescribed at least one opioid. Tramadol and oxycodone were the most common prescriptions. The data highlight the need for greater awareness of FDA-approved, non-opioid treatment options, including TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg), Tonix’s recently approved fibromyalgia therapy.
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA is the first new treatment for fibromyalgia in more than 15 years. The company’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace SymTouch and Tosymra.
Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Additionally, the company is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. The CNS portfolio also includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome.
The study’s findings are particularly important given the opioid crisis in the United States. For years, guidelines from organizations such as the American College of Rheumatology and the European League Against Rheumatism have recommended against using opioids for fibromyalgia due to limited efficacy and risks of dependence and adverse effects. Yet, the data show that many patients continue to receive these medications.
“These real-world data highlight a significant gap between clinical practice and evidence-based recommendations for fibromyalgia treatment,” said a company spokesperson. “We hope these findings will encourage healthcare providers to consider non-opioid options like TONMYA, which has been FDA-approved for the management of fibromyalgia.”
The full press release is available at https://ibn.fm/6AtjR. For more information about Tonix Pharmaceuticals, visit the company’s newsroom at https://ibn.fm/TNXP.
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