Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at 7th International Congress on Controversies in Fibromyalgia

Core Insights - TNX-102 SL is a sublingual formulation of cyclobenzaprine aimed at treating fibromyalgia, showing statistically significant pain reduction in two Phase 3 studies [1][2] - The FDA has set a PDUFA goal date of August 15, 2025, for TNX-102 SL's marketing authorization, potentially making it the first new treatment for fibromyalgia in over 15 years [1][2] - TNX-102 SL targets non-restorative sleep, which is linked to pain reduction, and is designed to have a durable effect lasting up to three months [2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and CNS disorders [6] - The company has a pipeline that includes TNX-102 SL for fibromyalgia and other candidates for various conditions, including acute stress reaction and cocaine intoxication [6][7] - Tonix's product candidates are investigational and have not yet established efficacy and safety [8] Industry Context - Fibromyalgia affects over 10 million adults in the U.S., primarily women, and is characterized by chronic pain, fatigue, and cognitive dysfunction [3][4] - Current treatments for fibromyalgia have been inadequate, leading to many patients being prescribed chronic opioids, which are often ineffective [2][4] - Fibromyalgia is recognized as a chronic overlapping pain condition, with a growing understanding of its mechanisms and treatment needs [4]