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TNX-102 SL advances to Phase 3 study in fibromyalgia
June 2015
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NEW YORK—Tonix Pharmaceuticals Holding Corp. has kicked off a Phase 3 clinical study to evaluate the efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablet, 2.8 mg) in fibromyalgia when taken daily at bedtime. The AFFIRM study will evaluate the compound’s safety as well as its ability to improve pain, sleep quality and other clinical measures, and Tonix expects top-line results in the second half of next year.
 
“We are proud to be developing a new prescription medicine for people suffering from a condition that, despite its prevalence, remains inadequately addressed,” said Dr. Seth Lederman, chairman and CEO of Tonix. “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.”
 
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