Fibromyalgia Patients Show Sleep Improvements in Tonmya Study

Fibromyalgia Patients Show Sleep Improvements in Tonmya Study
Tonix Pharmaceuticals Holding Corp., a company dedicated to the invention and development of next-generation products for fibromyalgia, episodic tension-type headache, and post-traumatic stress disorder (PTSD), recently presented additional data from its completed 12-week, Phase 2b BESTFIT clinical trial in 205 patients treated with Tonmya for fibromyalgia. Tonmya  is presently being assessed in the Phase 3 AFFIRM clinical trial in 500 patients with a diagnosis of fibromyalgia. As accepted by the FDA, the trial primary endpoint measure is a pain responder analysis, defined as the number of patients who report at least a 30% decrease in their baseline pain at the end of the treatment period of 12 weeks. The company is expecting to report top-line results from this trial during the third quarter of 2016. Of the 174-fibromyalgia patients who finished the BESTFIT clinical trial, 172 were eligible for the following analyses. Of these, 88-fibromylgia patients received treatment with Tonmya (TNX-102 SL; cyclobenzaprine HCl sublingual tablets, 2.8 mg), and 84 received treatment with a placebo composite. Data from a tertile analysis of reported improvements in sleep quality were retrieved from 54 fibromyalgia patients who described the highest improvement in sleep quality, or top sleep tertile. These patients were assessed in more detail. Of those fibromyalgia patients assigned in the Tonmya group, 41% were in the top sleep tertile versus 21% in the patients assigned to placebo. Of the 42 patients in the top sleep tertile who reported having experienced at least 30% of improvements in pain from baseline, 67% had been treated with Tonmya versus 33% with placebo. Results from other analyses assessing sleep quality in the BESTFIT trial revealed a correlation be
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