Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has reported positive topline results from its Phase 3 RESILIENT study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. The study met its pre-specified primary endpoint, demonstrating a statistically significant reduction in daily pain compared to placebo.
The RESILIENT study was a randomized, double-blind, placebo-controlled trial that enrolled patients diagnosed with fibromyalgia. Participants received either TNX-102 SL 5.6 mg or placebo taken sublingually each evening. The primary endpoint was the change from baseline to Week 14 in weekly averages of daily pain intensity scores as measured by a daily diary using an 11-point numerical rating scale (NRS). Secondary endpoints included measures of sleep quality, fatigue, and overall fibromyalgia impact.
According to the company, TNX-102 SL demonstrated a statistically significant improvement in pain reduction compared to placebo. The treatment was generally well-tolerated, with a safety profile consistent with previous studies. Detailed results from the RESILIENT study will be submitted for presentation at upcoming scientific conferences and for publication in peer-reviewed journals.
Based on the positive Phase 3 results, Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of TNX-102 SL for the management of fibromyalgia. If approved, TNX-102 SL would represent a novel therapeutic option for patients suffering from this chronic pain condition.
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and cognitive dysfunction. It affects an estimated 2-4% of the adult population, predominantly women. Current treatments for fibromyalgia include pain relievers, antidepressants, and exercise, but many patients continue to experience significant symptoms and seek alternative therapies. TNX-102 SL is designed to improve sleep quality, which may reduce pain and other fibromyalgia symptoms.
