Tonix Pharmaceuticals presents data on Tonmya at ACR Convergence

Tonix Pharmaceuticals (TNXP) presented data on Tonmya, which was investigated as TNX-102 SL, at the 2025 American College of Rheumatology Convergence, held October 24-29, 2025, in Chicago, Illinois. A copy of the Company’s presentation, titled “TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia,” is available under the Scientific Presentations tab of the Tonix website. The data presented at ACR come from RESILIENT, a 14-week randomized, double blind, placebo controlled trial at 34 U.S. sites, with 456 intent-to-treat 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, along with significant improvements in sleep quality and fatigue as well as the symptoms and function domains of the Fibromyalgia Impact Questionnaire. In an exploratory analysis, among female participants, Tonmya was associated with improvements in sexual function in total score and across multiple subscales of the Changes in Sexual Functioning Questionnaire versus placebo. Tonmya was well tolerated, with minimal impact on weight and blood pressure, no adverse sexual side effects and a low rate of adverse event-related discontinuations. The most common adverse events were mild and self-limited oral cavity reactions that rarely led to study withdrawal. “The results from RESILIENT further support Tonmya’s role as an innovative treatment option that addresses chronic and widespread pain, one of the most burdensome symptoms of fibromyalgia,” added Gregory Sullivan, CMO. “Tonmya’s favorable tolerability profile and unique formulation designed for bedtime sublingual administration offer patients and clinicians an important advancement in care.” Tonmya was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults.