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 Pharmace