By Daniella Parra
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) said it showed additional safety and tolerability data, marking the second positive Phase 3 study assessing TNX-102 SL for fibromyalgia management.
Tonix said the study met its primary endpoint, demonstrating statistically significant and clinically meaningful daily pain reduction over placebo. The results also revealed a favorable tolerability profile, including improvement in female sexual function and no increases in weight or blood pressure, common side effects in existing fibromyalgia medications, they said.
“We believe that the data from our two positive Phase 3 studies, with clinically meaningful separation from placebo on pain, sleep, and fatigue, show that fibromyalgia can be successfully treated by TNX-102 SL 5.6 mg and may provide the opportunity for Tonix to launch the first FDA-approved drug for fibromyalgia in more than a decade.” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix.