Pooled Efficacy From Two Phase 3 Pivotal Trials (RELIEF AND RESILIENT) of TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, in Participants with Fibromyalgia

Background and/or Objectives: Sublingual cyclobenzaprine (TNX-102 SL) significantly reduced pain in two separate Phase 3 studies in fibromyalgia (FM; RELIEF and RESILIENT studies); here, we assessed the effects of TNX-102 SL on FM symptoms and function by pooling these studies.

Design: RELIEF (NCT04172831) and RESILIENT (NCT05273749) pivotal studies were similarly designed 14-week, randomized, double-blind, placebo-controlled investigations.

Setting : Multicenter

Participants : Patients with FM

Interventions: Efficacy and safety of daily bedtime TNX-102 SL 5.6 mg vs placebo

Main Outcome Measures: The primary efficacy endpoint assessed the mean change from baseline to Week 14 in the weekly average of daily pain numeric rating scale intensity scores. Key secondary endpoints included proportion with Patient Global Impression of Change (PGIC) response (ie, “very much” or “much” improved) and change from baseline in the Fibromyalgia Impact Questionnaire – Revised (FIQR) Symptoms and Function domain scores, all at Week 14. Data were pooled for this analysis. Safety data will also be presented.

Results: In total, 959 patients (TNX-102 SL 5.6 mg, n=479; placebo, n=480) were included; 783 (81.6%) patients completed the studies. Mean (SD) age was 49.5 (10.3), 95.3% were female, and 85.9% were White/Caucasian. For the primary endpoint, the least-squares (LS) mean difference (95% CI) in change from baseline in pain score was -0.53 (-0.75, -0.30), significantly favoring TNX-102 SL vs placebo (P < 0.001). The PGIC “response” for TNX-102 SL vs placebo at Week 14 was 36% vs 25%, respectively (P < 0.001). The LS mean difference (95% CI) in change from baseline to Week 14 was -5.87 (-8.14, -3.61; P< 0.001) for FIQR Symptom domain score and -4.78 (-7.15, -2.42; P< 0.001) for FIQR Function domain score, significantly favoring TNX-102 SL.

Conclusions: In this pooled analysis, treatment with TNX-102 SL 5.6 mg significantly reduced pain scores, provided significantly greater patient-reported response rates, and was associated with significantly greater improvements in FIQR Symptom and Function domain scores vs placebo.