Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting

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 Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL, which, if approved, would be the first new non-opioid analgesic for fibromyalgia in over 15 years [1][6] - The drug targets non-restorative sleep, a common symptom in fibromyalgia, and has a favorable tolerability profile [2][5] Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company focused on CNS disorders and pain management, with TNX-102 SL as a priority product candidate [6] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [6] - Tonix also has a diverse portfolio, including products for acute stress reaction, cocaine intoxication, organ transplant rejection, and infectious diseases [6] 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 have been inadequate, leading to reliance on chronic opioids, which are often ineffective [2][3] - Fibromyalgia is recognized as a chronic overlapping pain condition, with a growing understanding of its mechanisms and treatment needs [3][4]