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 common 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, highlighting the need for greater awareness of FDA-approved, non-opioid treatment options.
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. This widespread use persists even though guidelines from major medical organizations advise against opioids for fibromyalgia due to limited efficacy and risks of addiction and adverse effects.
The data is particularly relevant given the ongoing opioid crisis in the United States. Fibromyalgia, a chronic condition characterized by widespread pain, fatigue, and cognitive difficulties, affects an estimated 4 million adults in the U.S. For over 15 years, no new treatments were approved for the condition until Tonix's TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg) received FDA approval. TONMYA offers a non-opioid alternative that may help reduce reliance on opioids.
“The findings underscore a gap between clinical practice and evidence-based recommendations and highlight the need for greater awareness of FDA-approved, non-opioid treatment options, including TONMYA,” the company stated in the press release. 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 SymTouch and Tosymra. 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 CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. The company is also advancing 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 data are significant for patients, healthcare providers, and the healthcare system. For patients, it highlights the availability of a new non-opioid treatment that may offer pain relief without the risks associated with opioids. For providers, it reinforces the importance of adhering to guidelines and considering non-opioid therapies. For the healthcare system, reducing opioid use in fibromyalgia could lower costs associated with opioid misuse and addiction.
For more information, visit the company’s newsroom at https://ibn.fm/TNXP and the full press release at https://ibn.fm/6AtjR.
