Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Core Insights - Tonmya is the first FDA-approved therapy for fibromyalgia in over 15 years, representing a significant advancement for the treatment of this chronic pain condition affecting over 10 million adults in the U.S. [1][2] - The approval of Tonmya was based on two pivotal Phase 3 clinical trials that demonstrated its efficacy in significantly reducing fibromyalgia pain compared to placebo [2][10] - Tonmya is expected to be commercially available in the fourth quarter of 2025 [1][6] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on developing treatments for central nervous system disorders, immunology, immuno-oncology, and infectious diseases [12][13] - The company has a proprietary formulation for Tonmya, which is a sublingual tablet designed for rapid absorption and reduced production of long half-life metabolites [9] Industry Context - Fibromyalgia is a chronic pain disorder that affects an estimated 10 million adults in the U.S., with approximately 80% being women. It is characterized by chronic widespread pain, fatigue, and sleep disturbances [8] - The chronic pain associated with fibromyalgia significantly disrupts patients' daily lives and is often inadequately managed due to a lack of effective treatment options [4][8]