Tonix Pharmaceuticals (US:TNXP) Globenewswire·2025-10-27 11:00Core Insights - Tonmya demonstrated significant reduction in fibromyalgia pain compared to placebo in the Phase 3 RESILIENT study, indicating its potential as a well-tolerated, non-opioid analgesic for adults with fibromyalgia [1][2] - The treatment was well tolerated with a discontinuation rate of 19% versus 20.8% for placebo, and minimal effects on weight or blood pressure [1][2] Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company with marketed products and a pipeline focused on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [4] - The company received FDA approval for Tonmya on August 15, 2025, marking the first new prescription medicine approval for fibromyalgia in over 15 years [3][4] - Tonix also markets treatments for acute migraine and is developing TNX-102 SL for acute stress reaction and major depressive disorder [4] Clinical Study Details - The RESILIENT study was a 14-week randomized, double-blind, placebo-controlled trial involving 456 participants across 34 U.S. sites, meeting the 2016 American College of Rheumatology criteria for fibromyalgia [2] - Statistically significant reductions in weekly average pain scores were observed at Week 14 (p<0.0001) compared to placebo, along with improvements in sleep quality, fatigue, and other fibromyalgia symptoms [2] Treatment Profile - Tonmya's favorable tolerability profile includes minimal impact on weight and blood pressure, no adverse sexual side effects, and a low rate of adverse event-related discontinuations [2][3] - The most common adverse events were mild oral cavity reactions, which rarely led to study withdrawal [2]