Efficacy and safety of TNX-102 SL in patients with fibromyalgia: a systematic review and meta-analysis.

Objective: TNX-102 SL is a new sublingual tablet formulation of cyclobenzaprine (CBP) for rapid transmucosal absorption. We aimed to evaluate the efficacy and safety of TNX-102 SL in improving pain and sleep quality in patients with fibromyalgia (FM).

Methods: Searches were conducted in Embase, PubMed, Cochrane Library, and Web of Science databases. The primary endpoint was the reduction in daily diary pain score. Secondary outcomes included Fibromyalgia Impact Questionnaire (FIQ-R) Function and Symptoms, daily diary sleep score, and adverse effects. Four studies met eligibility criteria and a random-effect meta-analysis was performed to combine data.

Results: The analyses of 1,993 patients yielded statistically significant differences in the TNX-102 SL group versus the control group on daily diary pain intensity (SMD = -0.25; 95% CI [-0.34, -0.16]; p < 0.001), FIQ-R Function (SMD = -0.18; 95% CI [-0.35, -0.02]; p = 0.028), FIQ-R Symptoms (SMD = -0.23; 95% CI [-0.33, -0.13]; p < 0.001) and sleep daily diary (SMD = -0.21; 95% CI [-0.32, -0.11]; p < 0.001). Sedation, oral hypoaesthesia, and paresthesia were TNX102-SL's most common adverse effects.

Conclusions: Pooled data show TNX-102 SL significantly reduces pain, improves sleep quality, and enhances quality of life in FM patients.

Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024588069.