Tonix Begins Phase 2b BESTFIT Trial Of Therapeutic Candidate TNX-102 SL

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) Monday said it began the Phase 2b Bedtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy or BESTFIT trial of its therapeutic candidate, TNX-102 SL 2.8 mg tablets, in patients with fibromyalgia. The top-line results are anticipated in the second half of 2014.

BESTFIT is a randomized; double-blind trial of TNX-102 SL versus placebo in patients diagnosed with primary fibromyalgia, and is expected to enroll about 120 patients. The primary endpoint of the trial is change in pain intensity at week 12 from baseline, as evaluated by scoring on the 11-point Numeric Rating Scale. Safety and tolerability of TNX-102 SL taken at bedtime over 12 weeks will also be evaluated.

"We continue to pursue opportunities for TNX-102 SL in other indications, including post-traumatic stress disorder," said Seth Lederman, chief executive officer and President of Tonix.