Results of safety and efficacy of sublingual cyclobenzaprine (TNX-102) in patients with fibromyalgia

A recent study has stated that the treatment with sublingual cyclobenzaprine (TNX-102 SL) was safe and well-tolerated in patients with fibromyalgia. The study findings have been published in the journal Arthritis & Research.

Dr. Lederman and his colleagues conducted a double-blind, randomized, placebo-controlled trial to evaluate pain reduction in fibromyalgia patients using TNX-102 SL. This study, which included 503 patients, reported a significant decrease in daily pain with TNX-102 after 14 weeks (approximately 3 months) in the study group. However, at week 14, the Patient Global Impression of Change did not show significant improvement due to TNX-102 SL. Nonetheless, there was an improvement in Fibromyalgia Impact Questionnaire-Revised scores, Patient-Reported Outcomes Measurement Information System, and daily sleep quality. The most frequently reported treatment-emergent adverse events overall by patients receiving TNX-102 SL and placebo were oral hypoesthesia (17.3% with TNX-102 SL vs. 0.4% with placebo), oral paresthesia (5.6% vs. 0.4%), and altered product taste (4.4% vs. 0.4%).

A 2021 placebo-controlled multicenter efficacy and safety trial showed reduced daily pain using TNX at the 5.6 mg dose during bedtime. It also showed improvement in sleep, fatigue, and other fibromyalgia symptoms. A 30% pain reduction responder analysis showed 46.8% TNX responders compared to 34.9% on placebo (p=0.006). According to Patient Global Impression of Change, 29.4% of those on the placebo had responders versus 37.5% of those using TNX (P=0.058). TNX demonstrated higher separation from placebo in terms of FIQ-R symptoms (p=0.007), function (p=0.009), PROMIS sleep disturbance (P <0.001), fatigue (P=0.018), and daily diary sleep quality (p<0.001).

In conclusion, the findings from these studies indicate that TNX-102 SL has a primary impact on sleep quality, which in turn may lead to a reduction in central sensitization. This improvement at the syndromal level is reflected in the broad-spectrum activity observed in fibromyalgia symptoms.

References

  1. Lederman S, Arnold LM, Vaughn B, Kelley M, Sullivan GM. Efficacy and Safety of TNX‐102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia: Results From the Randomized, Placebo‐Controlled RELIEF Trial. Arthritis Care & Research. 2023 May 11.
  2. Sullivan G, Kelley M, Iserson A, Peters P, Peters A, Flint C, et al. TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9).
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