Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented clinical data for TONMYA (previously TNX-102 SL) at the 2026 Non-Opioid Pain Therapeutics Summit held January 29, 2026, in Boston. The data were drawn from the RESILIENT trial, a 14-week Phase 3 randomized, double-blind, placebo-controlled study involving 456 patients with fibromyalgia. Results showed that bedtime sublingual administration of TONMYA led to a statistically significant reduction in weekly average pain scores at Week 14 versus placebo (p<0.0001), along with significant improvements in sleep disturbance, fatigue, and functional outcomes. Tonix reported that TONMYA was well tolerated, with low discontinuation rates and primarily mild, self-limited adverse events.
TONMYA is a first-in-class, non-opioid analgesic medicine approved by the FDA for the treatment of fibromyalgia, a chronic pain condition affecting millions of adults. It is the first new prescription medicine approved for fibromyalgia in more than 15 years. The RESILIENT trial reinforces TONMYA's profile as a differentiated, centrally acting treatment designed to address both pain and non-restorative sleep in fibromyalgia patients. The full press release is available at https://ibn.fm/VizLh.
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. In addition to TONMYA, Tonix markets two treatments for acute migraine in adults: Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray). The company's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, rare disease, and infectious disease. TNX-102 SL is also being developed for acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina, funded by the U.S. Department of Defense, and for major depressive disorder. Tonix's immunology portfolio includes TNX-1500, a Phase 2-ready Fc-modified humanized monoclonal antibody targeting CD40-ligand for prevention of allograft rejection and treatment of autoimmune diseases. The rare disease portfolio includes TNX-2900 (intranasal oxytocin potentiated with magnesium) for Prader-Willi syndrome, expected to start a potential pivotal Phase 2 study in 2026. The infectious disease portfolio includes TNX-801 for mpox and smallpox, TNX-4800 for Lyme disease prevention, and TNX-4200, a broad-spectrum antiviral agent under contract with the U.S. DoD's DTRA. Tonix owns and operates an infectious disease research facility in Frederick, Md.
For more information on Tonix Pharmaceuticals, visit the company's newsroom at https://ibn.fm/TNXP. This news matters because positive Phase 3 data for a new non-opioid treatment for fibromyalgia could offer a safer alternative to current therapies, addressing a significant unmet need for millions of patients suffering from chronic pain.
