Core Insights - TONMYA is the first FDA-approved treatment for fibromyalgia in over 15 years, providing a novel non-opioid option for patients [1][4] - The drug is now available by prescription nationwide, targeting the estimated 10 million adults in the U.S. suffering from fibromyalgia [2][7] - The approval is based on positive results from two Phase 3 clinical trials, demonstrating significant pain reduction compared to placebo [5][9] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on central nervous system disorders, immunology, and rare diseases [11] - The company operates a state-of-the-art infectious disease research facility and markets treatments for fibromyalgia and acute migraine [11] Product Details - TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented formulation that allows for rapid absorption and is taken once daily at bedtime [8] - The drug targets neurotransmitters involved in fibromyalgia, marking a significant advancement in treatment options for patients [3][4] Clinical Trial Information - The Phase 3 trials, RELIEF and RESILIENT, involved nearly 1,000 patients and showed that TONMYA significantly reduced daily pain scores at 14 weeks [5][9] - A greater percentage of participants experienced a clinically meaningful improvement in pain after three months compared to those on placebo [5] Market Potential - The approval of TONMYA is expected to address the long-standing need for effective treatments in a patient population that has historically faced limited options [2][3] - The patents associated with TONMYA are expected to provide market exclusivity until 2034, with potential extensions until 2044 [8]