157: Cyclobenzaprine HCl Sublingual Reduces Fibromyalgia Impact on Physical Symptoms & Functional Ability

Topic: Clinical Science
Subtopic:

Background and Aims: Cyclobenzaprine HCl sublingual tablets (CBP SL) are the first US FDA-approved therapy for adults with fibromyalgia in >15 years. In both of the pivotal phase 3 RELIEF (NCT04172831) and RESILIENT (NCT05273749) studies, CBP SL significantly reduced the weekly average of daily numeric rating scale pain scores versus placebo (primary endpoint) at Week 14.

Methods: This analysis evaluated the effect of CBP SL on fibromyalgia using the Fibromyalgia Impact Questionnaire-Revised (FIQR), a key secondary outcome measure in each study.

Results: In RELIEF and RESILIENT, CBP SL significantly reduced FIQR Symptoms total score at Week 14 (LS mean [SE] difference vs placebo of −4.3 [1.60], P=0.007 for RELIEF; −7.7 [1.62], P<0.001 for RESILIENT). CBP SL also significantly reduced FIQR Function total score at Week 14 (LS mean [SE] difference vs placebo of −4.4 [1.69]; P=0.009 for RELIEF and −5.4 [1.69]; P=0.001 for RESILIENT). At Weeks 2, 6, and 10, improvements in FIQR Symptoms and Function were seen in participants receiving CBP SL compared to placebo, with p-values <0.05 at nearly every week.

Conclusions: In patients with fibromyalgia, CBP SL significantly improved both physical symptoms and functional capacity, outcomes widely regarded as core therapeutic targets in fibromyalgia treatment.

Funding Source: Tonix Pharmaceuticals, Inc.

References: Lederman S, Arnold LM, Vaughn B, Kelley M, Sullivan GM. Efficacy and safety of sublingual cyclobenzaprine for the treatment of fibromyalgia: results from a randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2023;75(11):2359-2368.

Lederman S, Arnold LM, Vaughn B, Engels JM, Kelley M, Sullivan GM. Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine. Pain Med. 2026;27(1):86-94.

Presenting Author: Errol Gould
Submitting Author: Errol Gould

Senior Author: Errol Gould

IASP 2026 Global Year theme of Neuropathic Pain: No

• Errol Gould - Tonix Medicines, Inc.
• Jean Heilman - Tonix Pharmaceuticals, Inc.
• Gregory Sullivan - Tonix Pharmaceuticals, Inc.