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TNX-102 SL may improve sleep, pain scores in patients with fibromyalgia

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Sublingual TNX-102 SL improved sleep quality and other symptoms of fibromyalgia, according to research presented at the European League Against Rheumatism Annual European Congress of Rheumatology.

Researchers studied 205 patients with fibromyalgia in the BESTFIT 12-week, randomized, double-blind, placebo-controlled trial at 17 U.S. locations. Patients were randomly assigned at 1:1 ratio to receive TNX-102 SL (cyclobenzaprine hydrochloride, Tonix Pharmaceuticals) or placebo and kept a daily diary related to sleep and pain.

Patients were administered the Fibromyalgia Impact Questionnaire (FIQ-R), Patient Global Impression of Change (PGIC), PROMIS Sleep Disturbance scale (PROMIS) and Beck Depression Inventory (BDI) for mood. The mean change in scores from baseline was calculated with Mixed Effects Model Repeated Measures (MMRM).

The FIQ-R total score improved by 17.2 points compared with 9.1 points in the placebo group, and the FIQ-R sleep quality score improved by 2.9 points compared with 1.2 points in the placebo group. The PGIC improved by 30% compared with a 16.7% improvement in the placebo group, and the PROMIS score was reduced by 9.5 points in the treatment group compared with 6.1 points in the placebo group. Sleep measured in the daily diaries improved by 1.9 points compared with 1 point in the placebo group, and pain measured by diary was reduced overall by 1.6 points compared with 1.1 points in the placebo group.

Transient tongue or mouth numbness were the most common adverse events and occurred in 42% of patients. Few systemic adverse events were seen, occurring in less than 5% of patients, according to the researchers.

TNX-102 SL is currently being studied in the phase 3 AFFIRM trial for patients with fibromyalgia and in a phase 2 study of patients with posttraumatic stress disorder. – by Shirley Pulawski

Reference:

Lederman S, et al. Paper #THU0325. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosure: Lederman reports he is the CEO of Tonix Pharmaceuticals. No other financial information was disclosed.