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FDA clears sublingual cyclobenzaprine for phase 3 fibromyalgia trial
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Tonix Pharmaceuticals announced it has obtained written guidance from the FDA to begin a phase 3 trial of its sublingual form of cyclobenzaprine, TNX-102 SL, for the treatment of fibromyalgia.
“Getting this confirmation from the FDA — particularly its acceptance of the 30% responder analysis as the primary outcome measure — represents a clear step forward in our ongoing development of TNX-102 SL in fibromyalgia," Seth Lederman, MD, president and CEO of Tonix, said in a company press release.
In the phase 2b BESTFIT (BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy) trial of the drug, a statistically significant improvement in the 30% responder analysis was achieved. The study was designed as a 12-week, double-blind, placebo-controlled intervention, according to NIH clinical trial data. Approximately 200 participants were enrolled in the trial between September 2013 and December 2014.
The sublingual, 2.8-mg form of the drug is to be taken at bedtime and is intended as a first-line treatment of fibromyalgia and post-traumatic stress disorder.
Tonix will begin the phase 3 trial in the second quarter of 2015, according to the press release.
References: www.tonixpharma.com, www.clinicaltrials.gov.