Tonix Pharmaceuticals Holding Corp. presented data from its Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) at the ACR Convergence 2024 Annual Meeting, demonstrating statistically significant improvements in fibromyalgia symptoms. The study highlighted TNX-102 SL's potential as a novel, non-opioid treatment option for fibromyalgia, a condition affecting over 10 million adults in the U.S.
The RESILIENT study met its primary endpoint, showing a significant reduction in daily pain compared to placebo (p-value=0.00005) among participants with fibromyalgia. The trial also demonstrated broad benefits, with statistically significant improvements in all six pre-specified key secondary endpoints. These included enhanced sleep quality, reduced fatigue, and improved patient global ratings and overall fibromyalgia symptoms and function.
Targeting Non-Restorative Sleep
TNX-102 SL is designed as a bedtime treatment to target non-restorative sleep, a key characteristic of fibromyalgia. The sublingual formulation of cyclobenzaprine hydrochloride aims to improve sleep quality and, consequently, reduce pain and other associated symptoms. According to Tonix Pharmaceuticals CEO, Seth Lederman, M.D., TNX-102 SL has demonstrated statistically significant pain improvement in two Phase 3 studies, positioning it as a potential first new drug treatment option for fibromyalgia patients in 15 years.
Regulatory Pathway and Future Expectations
Tonix submitted a New Drug Application (NDA) to the FDA in October 2024 for TNX-102 SL for the management of fibromyalgia. The FDA is expected to decide on the NDA acceptance for review and assign a Prescription Drug User Fee Act (PDUFA) date in December. If the NDA is accepted, a decision on approval is anticipated in 2025.
About Fibromyalgia
Fibromyalgia is a chronic pain disorder characterized by amplified sensory and pain signaling within the central nervous system. Symptoms include chronic widespread pain, non-restorative sleep, fatigue, and cognitive dysfunction. It is recognized as a prototypic nociplastic syndrome, with many patients experiencing combinations of nociceptive, neuropathic, and nociplastic pain.
TNX-102 SL: A Novel Approach
TNX-102 SL is a centrally acting, non-opioid investigational drug designed for chronic use. The sublingual tablet formulation of cyclobenzaprine hydrochloride is intended for bedtime dosing. Cyclobenzaprine interacts with serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors in the brain, targeting the non-restorative sleep associated with fibromyalgia.
