During the European League Against Rheumatism Annual European Congress of Rheumatology held in Rome, researchers presented data showing sublingual TNX-102 SL improved sleep quality and other fibromyalgia symptoms. The study entitled “TNX-102 SL for the Treatment of Fibromyalgia: Role of Nonrestorative Sleep on Pain Centralization” was presented by S. Lederman from Tonix Pharmaceuticals, New York, USA.

Studies have suggested that nonrestorative sleep is very important in the pathophysiology of fibromyalgia (FM). Nonrestorative sleep has been associated to central sensitization, a process where regional chronic pain leads to alterations in central pain processing and interpretation.  Therefore therapies that improve sleep quality may ameliorate FM as a whole through a mechanism different from that of central acting analgesics.

TNX-102 SL is a sublingual formulation of cyclobenzaprine (2.8 mg) designed for rapid absorption and bedtime usage.  The current study was designed to evaluate the safety and efficacy of TNX-102 SL in the treatment of FM.

Researchers designed the BESTFIT clinical study, a 12-week, randomized, double-blind, placebo-controlled trial in 17 locations within the United States assessing a total of 205 patients with fibromyalgia. Subjects were randomly distributed toreceiver either TNX-102 SL (cyclobenzaprine hydrochloride, Tonix Pharmaceuticals) or placebo, and had a daily diary to annotate their sleep and pain status. The researchers applied a series of standard questionnaire and scales, such as Sleep Disturbance scale (PROMIS) and Beck Depression, to quantify fibromyalgia status.

TNX-102 SL is an experimental new drug that has not been yet approved for any pathological condition. During the study the most frequent adverse effects were temporary tongue or mouth numbness which occurred in 42% of patients.

Overall, the research team observed that TNX-102 SL given at bedtime improved sleep quality quantified by several methods. This improvement may be associated with progresses in several other symptoms of fibromyalgia.

Currently, TNX-102 SL is being evaluated in the phase 3 AFFIRM trial for patients with fibromyalgia and in a phase 2 study of patients with post-traumatic stress disorder.