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Tonix Pharma (TNXP) Says TNX-102 SL Phase 3 Did Not Meet Primary Endpoint in Fibromyalgia

September 6, 2016 7:11 AM EDT

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix) announced preliminary topline results from its Phase 3 clinical study, AFFIRM, designed to evaluate the safety and efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, in patients with fibromyalgia. AFFIRM was a 12-week randomized, double-blind, placebo-controlled trial of TNX-102 SL taken daily at bedtime, in which 519 participants were enrolled at 35 centers in the U.S. Fibromyalgia is a multi-symptom disorder that originates in the central nervous system and is characterized by widespread pain, non-restorative sleep, fatigue, and disability.

The AFFIRM data did not achieve... More