Tonix Pharmaceuticals Holding Corp. (TNXP) presented positive Phase 3 RESILIENT data today, showcasing the efficacy of TONMYA (cyclobenzaprine HCl sublingual tablets) in fibromyalgia at the 2026 Non-Opioid Pain Therapeutics Summit in Boston.
The findings underscored TONMYA's ability to significantly reduce fibromyalgia pain compared with placebo, reinforcing its role as a centrally acting, non-opioid treatment option.
Fibromyalgia affects more than 10 million adults in the U.S., and current therapies are often limited by tolerability challenges and side effects. TONMAY's sublingual formulation is designed for bedtime dosing and bypasses first-pass metabolism, optimizing parent-drug exposure during sleep while reducing levels of the persistent active metabolite.
The Phase 3 RESILENT trial was a 14-week, randomized, double-blind, placebo-controlled study conducted at 34 U.S. sites and enrolled 456 participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Treatment with TONMYA resulted in a statistically significant reduction in weekly average pain scores at Week 14 versus placebo. The study also demonstrated improvements in key secondary endpoints, including sleep disturbance, fatigue, and the Symptoms and Function domains of the Fibromyalgia Impact Questionnaire-Revised.
TONMYA was well tolerated, with minimal effects on weight and blood pressure. Adverse event-related discontinuations occurred in 6.1% of TONMYA-treated patients versus 3.5% in the placebo group. The most common adverse events were mild, self-limited oral cavity reactions.
According to the company's Chief Medical Officer, the sublingual formulation's ability to bypass first-pass hepatic metabolism reduces formation of norcyclobenzaprine, contributing to a pharmacokinetic profile that supports parent-drug exposure during sleep and limits daytime metabolite levels. This design aims to address non-restorative sleep, a central feature of fibromyalgia pathophysiology.
TONMYA was approved by the FDA on August 15, 2025, for the treatment of fibromyalgia in adults and is the first new prescription medicine for the condition in more than 15 years.
TONMYA became commercially available in the U.S. on November 17, 2025.
TNXP has traded between $6.76 and $69.97 over the past year. The stock is currently trading in the pre-market at $18.31, up 0.49%.
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