Real-World Analysis of Opioid Use in Patients With Fibromyalgia Presented at ASCP 2026

A new real-world claims analysis of opioid use in patients with fibromyalgia was presented by Tonix Pharmaceuticals at this year’s meeting of the American Society for Clinical Psychopharmacology.¹ Data showed continued prescription of opioids, present in about 40% adult patients with fibromyalgia, despite guidelines discouraging their use and a concern for worsened symptoms.²

“The discrepancy between real-world practice and evidence-based recommendations reveals a gap in knowledge and an urgent need to educate health care prescribers about the nature of fibromyalgia and the availability of non-opioid, FDA-approved medicines,” said Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals. “Tonix is currently executing on the launch of Tonmya (cyclobenzaprine HCl sublingual tablets), a first-in-class, first-line, non-opioid analgesic medicine FDA approved for daily bedtime administration and long-term use in adults with fibromyalgia,” he added.

The retrospective cohort study reviewed opioid and benzodiazepine prescribing for patients with fibromyalgia across different healthcare insurance claims from April 2021 to April 2024. Use of opioid or benzodiazepine medications was defined as the presence of 1 or more pharmacy claim for the medication during the observation period. Drug prevalence was collected for patients diagnosed with fibromyalgia (according to ICD-10 criteria) and characterized across age, insurance coverage, and polypharmacy. In the last cohort from 2023 to 2024, data included 261,776 patients (92.1% female, mean age 52.3, 49.6% White, non-Hispanic). Claims included were gathered from the Symphony Health closed claims database, which includes administrative medical and pharmacy claims, and included patients with continuous insurance for 3 years.

For patients using commercial or Medicare Advantage insurance, 40.2% of patients were prescribed at least 1 opioid, and among Medicaid patients, about 38.8% were prescribed at least 1 opioid. The most claims were filed for tramadol (13.7%) and oxycodone (13.1%) in commercial or Medicare patients. Medicaid claims showed similar prevalence, with most claims for oxycodone (15.7%) and tramadol (11.1%). Opioid prescription showed a higher incidence in older age groups: ages 61-65 (43.1%), ages 66-70 (39.2%), ages 71-71 (38.5%) and over 75 (34.4%). In younger adults aged 18-25, prevalence was lower but still significant, at 20.9%. Between Medicare or commercial insurance and Medicaid, concomitant opioid and benzodiazepine use was similar, with 19.1% and 20.4% respectively.

Tonmya, a non-opioid sublingual tablet, is approved by the FDA for treatment of fibromyalgia in adults—the first new medication for fibromyalgia in 15 years. Because it bypasses first pass hepatic metabolism, Tonmya provides rapid transmucosal absorption and reduced production of norcyclobenzaprine, an active metabolite. The compound is also being investigated for treatment of acute stress disorder/acute stress reaction and major depressive disorder.

References

1. Tonix Pharmaceuticals presented retrospective U.S. real-world claims analysis of opioid use in patients with fibromyalgia at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. Press release. May 28, 2026. Accessed May 28, 2026. https://ir.tonixpharma.com/news-events/press-releases/detail/1631/tonix-pharmaceuticals-presented-retrospective-u-s

2. Gould E, Whyte A. Opioid use in patients with fibromyalgia: a retrospective claims analysis. American Society for Clinical Psychopharmacology Annual Meeting. Poster presentation. Accessed May 28, 2026. https://www.tonixpharma.com/wp-content/uploads/2026/05/Tonix-ASCP-2026-Poster.pdf