Background Fibromyalgia (FM) is a chronic nociplastic pain syndrome marked by widespread pain, nonrestorative sleep, fatigue, and functional impairment. TNX-102 SL (cyclobenzaprine HCl sublingual) is a once-nightly, non-opioid therapy designed to improve sleep and reduce multi-domain FM symptoms. Methods We identified randomised, double-blind, placebo-controlled trials of TNX-102 SL in adults with FM. Outcomes included the weekly average daily pain, achieving ≥ 30% and ≥ 50% pain reduction, Patient Global Impression of Change, Fibromyalgia Impact Questionnaire-Revised (FIQ-R), and safety. Random-effects meta-analyses were performed with risk of bias assessed by RoB 2. Results Across four trials (total n = 1,684), TNX-102 SL significantly increased ≥ 30% pain responders (RR 1.44; 95% CI 1.15–1.81; I2 = 2.6%) and ≥ 50% pain responders (RR 1.43; 95% CI 1.12–1.82; I2 = 0%), and improved PGIC response (RR 1.52; 95% CI 1.29–1.79; I2 = 8.5%), compared with placebo. Although the TNX-102 SL did not significantly improve FIQR. Treatment-emergent adverse events were more frequent with TNX-102 SL (RR 1.41; 95% CI 1.26–1.57; I2 = 0%), driven by transient oral side effects: oral hypoesthesia (RR 38.11; 95% CI 18.55–78.29), oral paresthesia (RR 7.88; 95% CI 4.75–13.05), and abnormal taste (RR 10.92; 95% CI 6.74–17.69). Discontinuation rates were similar to placebo (RR 1.03; 95% CI 0.78–1.36; I2 = 0%), and no deaths were reported. Conclusions This meta-analysis of TNX-102 SL for fibromyalgia found that once-nightly sublingual cyclobenzaprine produced consistent improvements in pain response and global impression compared to placebo, with a good tolerability profile. TNX-102 SL represents an essential new non-opioid option for fibromyalgia.<Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="justify" colname="c1" colnum="1" /> <colspec align="justify" colname="c2" colnum="2" /> <tbody> <row> <entry nameend="c2" namest="c1"> Key Points • In a meta-analysis of four randomized, double-blind trials (n = 1,684), TNX-102 SL increased ≥ 30% and ≥ 50% pain responder rates versus placebo (RR 1.44 and 1.43; low heterogeneity). • TNX-102 SL improved Patient Global Impression of Change (RR 1.52), while FIQ-R scores -were not significantly different from placebo. • Treatment-emergent adverse events were more frequent and primarily transient oral effects (hypoesthesia, paresthesia, dysgeusia), with similar discontinuation rates and no reportd deaths. </entry> </row> </tbody> </tgroup> </Table>

Short-term efficacy and safety of sublingual cyclobenzaprine for fibromyalgia: A systematic review and meta-analysis

期刊论文
发表日期：

2025年11月29日

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Abd-alrahman Al-Qudah,
Mohammad Al-Hanaktah

摘要

Background

Fibromyalgia (FM) is a chronic nociplastic pain syndrome marked by widespread pain, nonrestorative sleep, fatigue, and functional impairment. TNX-102 SL (cyclobenzaprine HCl sublingual) is a once-nightly, non-opioid therapy designed to improve sleep and reduce multi-domain FM symptoms.

Methods

We identified randomised, double-blind, placebo-controlled trials of TNX-102 SL in adults with FM. Outcomes included the weekly average daily pain, achieving ≥ 30% and ≥ 50% pain reduction, Patient Global Impression of Change, Fibromyalgia Impact Questionnaire-Revised (FIQ-R), and safety. Random-effects meta-analyses were performed with risk of bias assessed by RoB 2.

Results

Across four trials (total n = 1,684), TNX-102 SL significantly increased ≥ 30% pain responders (RR 1.44; 95% CI 1.15–1.81; I² = 2.6%) and ≥ 50% pain responders (RR 1.43; 95% CI 1.12–1.82; I² = 0%), and improved PGIC response (RR 1.52; 95% CI 1.29–1.79; I² = 8.5%), compared with placebo. Although the TNX-102 SL did not significantly improve FIQR. Treatment-emergent adverse events were more frequent with TNX-102 SL (RR 1.41; 95% CI 1.26–1.57; I² = 0%), driven by transient oral side effects: oral hypoesthesia (RR 38.11; 95% CI 18.55–78.29), oral paresthesia (RR 7.88; 95% CI 4.75–13.05), and abnormal taste (RR 10.92; 95% CI 6.74–17.69). Discontinuation rates were similar to placebo (RR 1.03; 95% CI 0.78–1.36; I² = 0%), and no deaths were reported.

Conclusions

This meta-analysis of TNX-102 SL for fibromyalgia found that once-nightly sublingual cyclobenzaprine produced consistent improvements in pain response and global impression compared to placebo, with a good tolerability profile. TNX-102 SL represents an essential new non-opioid option for fibromyalgia.

Key Points

• In a meta-analysis of four randomized, double-blind trials (n = 1,684), TNX-102 SL increased ≥ 30% and ≥ 50% pain responder rates versus placebo (RR 1.44 and 1.43; low heterogeneity).

• TNX-102 SL improved Patient Global Impression of Change (RR 1.52), while FIQ-R scores -were not significantly different from placebo.

• Treatment-emergent adverse events were more frequent and primarily transient oral effects (hypoesthesia, paresthesia, dysgeusia), with similar discontinuation rates and no reportd deaths.