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.
“Fibromyalgia is one of the most common chronic pain conditions, and yet despite approved medications, the majority of patients either do not respond to, or cannot tolerate, these products,” said the Director of the Chronic Pain and Fatigue Research Center at the University of Michigan and a consultant at Tonix, Dr. Daniel J. Clauw in the press release. “The efficacy and tolerability profile of TNX-102 SL as demonstrated in prior clinical evaluations supports this candidate as a promising treatment for fibromyalgia.”
“We are proud to be developing a new prescription medicine for people suffering from a condition that, despite its prevalence, remains inadequately addressed,” added Tonix CEO Dr. Seth Lederman. “If approved, we believe TNX-102 SL would offer a clinical profile that would be highly differentiated from currently-marketed drug products, and would be the first medicine for fibromyalgia to target non-restorative sleep.”
Tonix is currently recruiting fibromyalgia patients for its Phase 3 AFFIRM clinical trial (NCT02436096). If you are interested in participating please contact Mark R. Schmal via e-mail [email protected] or + 1 512 852 6912. For a list of the 35 study locations recruiting participants please follow the link.