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TNX-102 SL, cyclobenzaprine HCl sublingual tablets, demonstrates pain reduction and favorable tolerability in patients with fibromyalgia

P-037 - (Poster #37) TNX-102 SL, cyclobenzaprine HCl sublingual tablets, demonstrates pain reduction and favorable tolerability in patients with fibromyalgia

Thursday, September 4, 2025
4:00 PM - 5:30 PM PST
Location:  Exhibit Hall (Level 4)
Background: FDA-approved treatments for fibromyalgia (FM) have historically been limited by intolerable side effects that often lead to poor adherence. TNX-102 SL, a sublingual formulation of cyclobenzaprine, is under evaluation by the FDA as a treatment for FM. TNX-102 SL treatment has shown statistically significant reductions in pain in two Phase 3 studies, including the RESILIENT study reported below. In these studies, TNX-102 SL was generally well tolerated. The tolerability of TNX-102 SL may make it an appealing alternative to existing therapies.

Purpose/Objectives: To report the tolerability of TNX-102 SL in the treatment of FM from the Phase 3, randomized, placebo-controlled study, RESILIENT.

Methods: The RESILIENT study was a 14-week, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL in patients with FM. The pre-specified primary endpoint was the change from baseline to Week 14 in the weekly average of daily pain numeric rating scale (NRS) scores, analyzed using a mixed model for repeated measures with multiple imputation for missing data. Exploratory secondary endpoints included assessments of tolerability, such as changes in sexual function (measured by the Changes in Sexual Functioning Questionnaire short form [CSFQ-14]) and weight gain. Safety evaluations included changes in blood pressure and the incidence of adverse events (AEs).

Results: Compared to placebo, TNX-102 SL demonstrated significant improvement in the primary pain endpoint (p< 0.0001) at Week 14. Female patients treated with TNX-102 SL had significantly greater improvements in desire/frequency (p=0.010), orgasm/completion (p=0.007), and total sexual function scores (p = 0.010). No significant differences in weight, systolic, or diastolic blood pressure were observed between TNX-102 SL and placebo at Week 14. The most commonly reported AEs were mild to moderate, self-limited events such as transient tongue or mouth numbness and bitter aftertaste, which rarely led to study discontinuation. Systemic AE rates, excluding COVID-19, remained below 4.0%.

Conclusions/Implications for future research and/or clinical care:

TNX-102 SL significantly reduced pain and showed a favorable tolerability profile, including minimal impact on weight and blood pressure. Along with its unique mechanism targeting sleep disturbances, these results support its potential as a new treatment option for FM. The availability of a well-tolerated treatment may also encourage clinicians to make the diagnosis of FM earlier, thereby improving patient outcomes through timely intervention.

 
Supported by: Tonix Pharmaceuticals.