BERKELEY HEIGHTS, New Jersey, United States — October 27, 2026
Tonix Pharmaceuticals Holding Corp., a commercial-stage biopharmaceutical company focused on central nervous system disorders, infectious diseases and immunology, presented an analysis of Phase III clinical trial data demonstrating that TONMYA® (cyclobenzaprine hydrochloride sublingual tablets) improved physical symptoms and functional ability in adults with fibromyalgia. The findings were presented at the International Association for the Study of Pain (IASP) 2026 World Congress on Pain, held in Bangkok, Thailand, from October 26–30, 2026. The analysis examined results from the pivotal RELIEF and RESILIENT studies, which evaluated changes in the Fibromyalgia Impact Questionnaire-Revised (FIQR) Symptoms and Function domains. In both trials, participants receiving TONMYA experienced greater improvements than those receiving placebo, with statistically significant results at Week 14 across both domains in RESILIENT and nominally significant findings in RELIEF. TONMYA was approved by the U.S. Food and Drug Administration (FDA) in August 2025 for treating fibromyalgia in adults and was commercially launched in November 2025. The latest analysis adds to the clinical evidence supporting the medicine’s potential role in managing symptoms and improving everyday functioning for eligible patients.
Phase 3 Trials Demonstrate Improvements in Fibromyalgia Symptoms and Function
The RELIEF and RESILIENT studies were randomized, double-blind, placebo-controlled Phase III trials designed to assess the efficacy and safety of TONMYA over 14 weeks in adults diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria. Participants were randomized in a 1:1 ratio to receive TONMYA or matching placebo. The treatment regimen began with 2.8 mg sublingually at bedtime for two weeks, followed by 5.6 mg nightly through Week 14. The primary efficacy endpoint was the change from baseline in the weekly average of daily self-reported pain scores on a 0–10 numeric rating scale. Key secondary endpoints included changes in FIQR Symptoms and Function domain scores, which assess fibromyalgia-related symptoms and the impact of the condition on physical activities. Across both studies, TONMYA recipients showed greater reductions in symptoms and functional impairment than placebo recipients at Weeks 2, 6, 10 and 14. At Week 14, results were statistically significant for both domains in RESILIENT (p≤0.001) and nominally significant in RELIEF (p<0.01). The findings suggest that treatment may improve multiple aspects of fibromyalgia burden, although the results should be interpreted within the design and statistical testing framework of the trials.
Safety Findings Remain Consistent With Previous Clinical Studies
Tonix reported that TONMYA was generally well tolerated in the RELIEF and RESILIENT trials, with an adverse-event profile consistent with previous studies and no new safety signals identified. The most common treatment-emergent adverse events were local reactions associated with oral administration. TONMYA is a sublingual formulation of cyclobenzaprine hydrochloride designed for absorption through the tissues beneath the tongue. According to the company, the formulation supports transmucosal absorption and reduces the production of the long-half-life active metabolite norcyclobenzaprine by bypassing first-pass hepatic metabolism. The medicine acts on multiple receptor systems, including serotonergic, adrenergic, histaminergic and muscarinic receptors. These pharmacological properties form part of the scientific rationale for its development in fibromyalgia, a chronic condition associated with widespread pain, fatigue, nonrestorative sleep, stiffness and difficulties with daily activities. Although the trial findings provide further information about tolerability, patients should use TONMYA according to its approved prescribing information and under the guidance of a healthcare professional. Continued post-marketing experience and further research will help characterize its safety and effectiveness in routine clinical practice.
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TONMYA Advances Tonix’s Commercial and Clinical Development Strategy
TONMYA is Tonix Pharmaceuticals’ flagship internally developed medicine and, according to the company, the first newly approved prescription treatment for fibromyalgia in more than 15 years. The company commercially launched the product in November 2025 and is using its central nervous system commercial infrastructure to support its marketed portfolio, which also includes Zembrace® SymTouch® and Tosymra® for acute migraine. Tonix is continuing to investigate the underlying TNX-102 SL formulation in clinical studies for additional potential indications, including major depressive disorder and acute stress disorder or acute stress reaction; these uses remain investigational and are not approved indications. Beyond its CNS portfolio, the company is advancing development programs in infectious diseases and immunology, including candidates targeting Lyme disease prevention, mpox and smallpox prevention, and kidney transplant rejection. The latest TONMYA analysis reinforces the company’s focus on treatments addressing conditions with substantial unmet medical needs. Fibromyalgia affects millions of adults in the United States and can substantially interfere with quality of life and daily functioning. By presenting the RELIEF and RESILIENT findings at an international pain research congress, Tonix aims to increase awareness of the clinical evidence supporting TONMYA and its potential contribution to fibromyalgia management.
Source:Tonix Pharmaceuticals, Press release
