Tonix Pharmaceuticals Presented Data on TONMYA™ in Treating Patients with Fibromyalgia at the 2026 AAPM PainConnect Annual Meeting

Core Insights - Tonix Pharmaceuticals has launched TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia treatment, marking the first new prescription medicine for this condition in over 15 years [2][7] - The drug demonstrated statistically significant pain reduction in Phase 3 trials and was well tolerated by patients [1][2] Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company focused on central nervous system (CNS) and immunology treatments, addressing high unmet medical needs [8] - The company’s flagship product, TONMYA, is supported by a commercial infrastructure that includes other marketed products for acute migraine [8] Product Details - TONMYA is designed to provide rapid absorption and reduce the formation of the active metabolite norcyclobenzaprine, which can interfere with treatment durability [2][6] - The FDA approved TONMYA in August 2025 based on the results of the Phase 3 RESILIENT trial, which involved 457 patients [2][7] Clinical Trial Results - The Phase 3 RESILIENT trial showed a statistically significant reduction in mean daily pain at 14 weeks, with an increase in the number of patients achieving a 30% reduction in pain compared to placebo [2] - Common adverse events were mild and primarily related to oral cavity reactions, leading to low withdrawal rates from the study [2] Market Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., with a significant majority being women, and is characterized by chronic pain, fatigue, and sleep disturbances [5] - Current FDA-approved treatments for fibromyalgia are limited by side effects and high discontinuation rates, positioning TONMYA as a promising alternative [2][5]