Tonix Pharmaceuticals Reveals High Opioid Use Among Fibromyalgia Patients Despite Guidelines

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented data at the 2026 American Society of Clinical Psychopharmacology Annual Meeting revealing that opioid use remains common among U.S. adults diagnosed with fibromyalgia, despite longstanding treatment guidelines discouraging their use. The findings, based on a retrospective analysis of more than 261,000 patients in the Symphony Health claims database, showed that approximately 40% of commercially insured, Medicare Advantage and Medicaid patients with fibromyalgia were prescribed at least one opioid, with tramadol and oxycodone representing the most common prescriptions.

Tonix Pharmaceuticals stated that the findings underscore a significant gap between clinical practice and evidence-based recommendations, highlighting the need for greater awareness of FDA-approved, non-opioid treatment options, including TONMYA(R), the company’s recently approved fibromyalgia therapy. TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg) is the first new treatment for fibromyalgia in more than 15 years. The full press release is available at https://ibn.fm/6AtjR.

Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, and cognitive difficulties, affecting millions of Americans. Despite guidelines from the American Pain Society and the American Academy of Pain Medicine recommending against opioids as first-line therapy, the study indicates that opioids are still widely prescribed. This raises concerns about the potential for addiction, overdose, and other adverse effects, especially given the ongoing opioid crisis in the United States.

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. The company’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace(R) SymTouch(R) and Tosymra(R). Tonix is also maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. Additionally, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. 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.

The implications of this study are significant for healthcare providers and policymakers. It suggests that despite clear guidelines, many patients are still being prescribed opioids, potentially due to a lack of awareness of non-opioid alternatives or limited access to specialized care. The data emphasize the need for educational initiatives and improved access to FDA-approved treatments like TONMYA to align clinical practice with evidence-based recommendations.

For more information on Tonix Pharmaceuticals and its latest news, visit the company’s newsroom at https://ibn.fm/TNXP. Note to investors: The product development candidates mentioned are investigational new drugs or biologics, and their efficacy and safety have not been established for any indication.