Tonix reports Phase 3 TONMYA data showing improved fibromyalgia symptom and function scores versus placebo in the RELIEF and RESILIENT trials.
Written By: Saniya Katakdhond, PharmD
Reviewed By: Pharmacally Editorial Team
Tonix Pharmaceuticals presented an analysis of its Phase 3 RELIEF and RESILIENT studies evaluating TONMYA® (cyclobenzaprine hydrochloride sublingual tablets) in adults with fibromyalgia at the International Association for the Study of Pain (IASP) 2026 World Congress on Pain, held October 26–30 in Bangkok, Thailand.
The analysis assessed changes in the Symptoms and Function domains of the Fibromyalgia Impact Questionnaire-Revised (FIQR). According to Tonix, participants receiving TONMYA experienced greater improvements than those receiving placebo at Weeks 2, 6, 10 and 14 in both trials. At Week 14, both domains were statistically significant in RESILIENT and nominally significant in RELIEF.
The findings extend the reported efficacy evidence beyond the primary pain endpoint to patient-reported symptoms and functioning. However, the company announcement did not provide numerical FIQR changes or between-group effect sizes, limiting assessment of the magnitude of these improvements.
Phase 3 Trial Design and Efficacy Measures
RELIEF and RESILIENT were randomized, double-blind, placebo-controlled Phase 3 trials evaluating 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. Treatment began at 2.8 mg at bedtime for two weeks, followed by 5.6 mg at bedtime through Week 14.
The primary efficacy endpoint in both studies was the change from baseline in the weekly average of daily self-reported pain scores, measured using a 0–10 numeric rating scale. Key secondary endpoints included changes in FIQR Symptoms and Function domain scores.
The FIQR assesses fibromyalgia symptom burden and its impact on daily functioning over the preceding seven days. The reported analysis evaluated outcomes at Weeks 2, 6, 10 and 14, with Week 14 designated as the prespecified timepoint of interest.
Improvements Reported Across Both Trials
Tonix reported greater reductions from baseline in both FIQR domain scores with TONMYA than with placebo at all four assessment timepoints in RELIEF and RESILIENT.
At Week 14, both domains achieved statistical significance in RESILIENT, with p-values of ≤0.001. In RELIEF, both domains were nominally significant, with p-values of <0.01. The company attributed the distinction to the hierarchical testing procedure used to control the risk of type I error across endpoints.
The company also reported statistically and clinically significant improvements over placebo in the primary pain endpoint at Week 14 in both studies.
The consistent direction of the FIQR findings across two placebo-controlled trials supports further consideration of TONMYA’s effects on patient-reported symptoms and functioning. Nevertheless, statistical significance does not establish the magnitude of benefit experienced by individual patients. Without numerical FIQR changes, confidence intervals or responder analyses in the announcement, the size and clinical relevance of these domain-specific effects cannot be independently assessed from the reported information.
Safety and Tolerability
TONMYA was generally well tolerated, with a safety profile consistent with previous studies. Tonix reported no new safety signals, and local oral administration-site reactions were the most common treatment-emergent adverse events.
The FDA prescribing information lists oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth and aphthous ulcers among the common adverse reactions.
Important prescribing considerations include serotonin syndrome with certain concomitant medicines, central nervous system depression and potential fetal harm based on animal data. Contraindications include hypersensitivity to the ingredients, specified cardiac conditions, hyperthyroidism and concomitant monoamine oxidase inhibitor use, including within 14 days of discontinuation.
Clinical Interpretation
Fibromyalgia affects pain perception, symptoms and the ability to carry out everyday activities. The reported FIQR improvements suggest that TONMYA’s observed effects may extend beyond pain reduction to other patient-reported dimensions of the condition.
The distinction between the two studies remains important. Both FIQR domains were statistically significant at Week 14 in RESILIENT, whereas the RELIEF findings were nominally significant under the reported hierarchical testing procedure. The results therefore show a consistent direction of benefit, but the statistical evidence differed between trials.
The FDA approved TONMYA for fibromyalgia in adults on August 15, 2025. The latest analysis adds evidence on patient-reported symptoms and functioning for an already approved treatment. However, the absence of numerical FIQR effect estimates in the announcement prevents a quantitative assessment of the additional functional benefit.
Reference
Tonix Pharmaceuticals Presented an Analysis of Phase 3 Data Demonstrating TONMYA® Improved Physical Symptoms and Functional Ability of Patients with Fibromyalgia at the IASP 2026 World Congress on Pain. Tonix Pharmaceuticals Holding Corp, October 27, 2026.
A Study to Evaluate the Efficacy and Safety Of TNX-102 SL In Patients with Fibromyalgia (RELIEF), ClinicalTrials.gov ID NCT04172831
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients with Fibromyalgia (RESILIENT), ClinicalTrials.gov ID NCT05273749
About the Writer
Saniya Sanjay Katakdhond (Linkedin) is a Doctor of Pharmacy professional with hands-on experience in patient case review, clinical documentation, medical record analysis, and patient care.
Her hospital experience has strengthened her understanding of clinical conditions, treatment approaches, and multidisciplinary healthcare practices.
With ICH-GCP certification and a research-oriented approach, she brings clinical insight and attention to detail to healthcare content development.
As a healthcare writer, Saniya focuses on translating clinical knowledge and patient-care experience into clear, accurate, and evidence-informed medical content.