Tonix Fibromyalgia Treatment Shows Superior Pain Relief in Phase 3 Trial, FDA Decision Looms

Tonix Pharmaceuticals (NASDAQ:TNXP) has published results from its Phase 3 RESILIENT trial of TNX-102 SL for fibromyalgia in Pain Medicine journal. The trial demonstrated statistically significant improvement in reducing fibromyalgia pain compared to placebo, with a 1.8-point reduction versus 1.2-point for placebo on the daily pain scale.

The study, involving 457 adults across 33 U.S. sites, showed significant improvements across all six key secondary endpoints. TNX-102 SL was generally well-tolerated, with mild side effects. The FDA's PDUFA decision date is set for August 15, 2025, and if approved, it would be the first new fibromyalgia treatment in over 15 years.

https://www.stocktitan.net/news/TNXP/tonix-pharmaceuticals-announces-on-line-publication-of-phase-3-6ow0jnn18mr5.html