The following article is a part of conference coverage from the 2019 American College of Rheumatology/The Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, being held in Atlanta, Georgia. The team at Rheumatology Advisor will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the 2019 ACR/ARP Annual Meeting.
ATLANTA — Investigational new drug TNX-102 SL may provide clinically meaningful effects on function, fatigue, and sleep quality in patients with fibromyalgia, according to research results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia.
Researchers conducted a phase 3, double-blind, randomized, placebo-controlled, multicenter clinical trial to evaluate the safety and efficacy of TNX-102 SL, a sublingual formulation of cyclobenzaprine, for the treatment of fibromyalgia.
In total, 519 patients who met the ACR 2010 fibromyalgia criteria were enrolled in the 12-week trial. Patients randomly received either TNX-102 SL 2.8 mg (n=262) or placebo (n=257). The primary efficacy end point was an analysis of patients who reported a ≥30% reduction in daily diary pain from baseline. Secondary outcome measures included researcher analyses of diary mean pain and sleep ratings, Fibromyalgia Impact Questionnaire results, Patient Global Impression of Change, and Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance scales.
Statistical significance was not achieved at primary end point; only 28.6% of the treatment group and 22.6% of the placebo group reported a reduction in pain (odds ratio, 1.41; 95% CI, 0.94-2.10; P =.095). Significant effects on pain reduction vs placebo were noted when assessed by standard approaches.
The TNX-102 SL 2.8 mg formulation improved the Fibromyalgia Impact Questionnaire total score in the treatment vs placebo group (-13.7 vs -7.5, respectively; P<.001) and the Patient Global Impression of Change responder rate (23.7% vs 16.3%, respectively; P=.038). Sleep quality measures also improved, including those measured by the PROMIS Sleep Disturbance scale (-8.0 vs -4.7, respectively; P<.001).
Investigators noted that systemic adverse events were infrequent; the only adverse event reported in ≥5% of the treatment group was fatigue (5.7% vs 2.3%, respectively). The most common adverse events were local oral events, including transient oral hypoaesthesia, glossodynia, paresthesia oral, and abnormal product taste.
Overall, fewer patients in the treatment vs placebo group completed the study (77.5% vs 86.4%, respectively).
“Bedtime TNX-102 SL 2.8 mg, although failing to achieve statistical significance…had clinically meaningful effects on pain and sleep,” the researchers concluded. “Moreover, there were robust effects of TNX-102 SL at 2.8 mg on the broad array of measures of [fibromyalgia] symptoms and function, fatigue, and particularly on measures of sleep quality.”
They added, “Poststudy analyses suggest that a higher dose of TNX-102 SL may be needed to meaningfully improve pain symptoms in a greater percentage of treated patients.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Sullivan G, Gendreau RM, Gendreau J, Peters A, Peters P, Lederman, S. A phase 3 randomized, double-blind, placebo-controlled trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) for the treatment of fibromyalgia (FM): evidence for a broad spectrum of activity on the FM syndrome. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 827.