Tonix Pharmaceuticals Holding Corp has begun a Phase 3 clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablet, 2.8 mg) in fibromyalgia, having recently randomized the first patient. The study is expected to enroll approximately 500 patients with fibromyalgia at approximately 35 clinical centers in the United States.

“We are proud to be developing a new prescription medicine for people suffering from a condition that, despite its prevalence, remains inadequately addressed,” says Seth Lederman, MD, chairman and CEO of Tonix, in a release. “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.”

The randomized, double-blind, placebo-controlled “AFFIRM” study will evaluate the efficacy of TNX-102 SL taken daily at bedtime in improving pain, sleep quality, and other clinical measures, as well as the safety of TNX-102 SL. As accepted by the US Food and Drug Administration (FDA), the primary outcome assessment for the study will be a pain responder analysis, defined as the proportion of patients who report at least a 30% reduction in pain from baseline at the end of the 12-week treatment period. Tonix expects to report top-line results from the AFFIRM study in the second half of 2016. To learn more, please visit (NCT02436096).

Daniel J. Clauw, MD, professor of anesthesiology, medicine (rheumatology), and psychiatry and director of the Chronic Pain and Fatigue Research Center at the University of Michigan, and a consultant to Tonix, says, “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. The efficacy and tolerability profile of TNX-102 SL as demonstrated in prior clinical evaluations supports this candidate as a promising treatment for fibromyalgia.”