Tonix Pharmaceuticals Launches Phase 3 Clinical Trial To Evaluate Experimental Fibromyalgia Therapy

Tonix Pharmaceuticals Launches Phase 3 Clinical Trial To Evaluate Experimental Fibromyalgia Therapy
Tonix Pharmaceuticals Holding Corp. recently announced the beginning of a Phase 3 clinical trial for its product TNX-102 SL (cyclobenzaprine HCl sublingual tablet, 2.8 mg) for the treatment of fibromyalgia. The company expects to enroll approximately 500 fibromyalgia patients in 35 clinical centers in the United States. Fibromyalgia is a medical disorder characterized by a set of symptoms that includes widespread chronic musculoskeletal pain, incapacitating fatigue, stiffness and numbness in certain parts of the body, painful response to pressure, headaches, unrefreshing sleep (poor sleep quality), anxiety or depression and mood alterations. It is thought that this disorder results from amplified sensory and pain signaling. Fibromyalgia can affect people’s ability to conduct simple daily tasks, compromising their quality of life. It is estimated that 5 to 15 million Americans are affected by this disorder, especially women. Tonix’s goal with TNX-102 SL is to address fibromyalgia by improving the patient’s sleep quality and consequently mitigate the pain and other disease symptoms. TNX-102 SL sublingual formulation was designed to be taken at bedtime. The goal of this Phase 3 randomized, double-blind, placebo-controlled AFFIRM trial is to evaluate the safety and efficacy of sublingual TNX-102 SL tablet taken daily for a 12-week treatment period. Researchers will assess improvement in sleep quality, pain, and other clinical indicators. The primary efficacy outcome assessment for this trial is a pain responder analysis, which was established as the proportion of patients who report at least a 30% decrease in pain at the end of the study. Results on the AFFIRM trial are expected in the second half of 2016. “Fibr
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