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Review
. 2025 Oct 5:1-9.
doi: 10.1080/17581869.2025.2569299. Online ahead of print.

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

Bárbara Ghizoni Maggi  1 , Natan Lucca Lima  1 , Luís Henrique Correa de Lara  1 , Maria Júlia Hallack Moura  1 , Davi Orli Machado Grüdtner  1 , José Pedro Duarte Hillal  2
Affiliations
Review

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

Bárbara Ghizoni Maggi et al. Pain Manag. .

Abstract

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.

Keywords: Cyclobenzaprine; fibromyalgia; meta-analysis; pain management; sublingual administration.

Plain language summary

Fibromyalgia (FM) is a condition that causes widespread pain, tiredness, and trouble sleeping. This study looked at how well a medicine called TNX-102 SL works to reduce pain and improve sleep in people with FM. We reviewed four high-quality clinical trials with almost 2,000 patients. The results show that TNX-102 SL helps reduce daily pain and improves sleep quality compared to a placebo (a pill with no active medicine). It also helped improve patients’ overall quality of life. However, some patients using TNX-102 SL experienced side effects like feeling sleepy, changes in taste, and unusual mouth sensations. These effects were more common than in patients taking the placebo. This medicine is promising, but more research is needed to understand its long-term safety and how well it works for different groups of people. Our findings support TNX-102 SL as a helpful option for managing FM symptoms, especially for those who struggle with pain and sleep problems.

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