Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a commercial-stage biopharmaceutical company, presented data from its Phase 3 RELIEF and RESILIENT studies demonstrating that TONMYA (cyclobenzaprine HCl sublingual tablets) improved physical symptoms and functional capacity in adults with fibromyalgia. The findings were presented at the International Association for the Study of Pain 2026 World Congress on Pain, held Oct. 26-30 in Bangkok, Thailand.
Both randomized, double-blind, placebo-controlled trials evaluated TONMYA against placebo over 14 weeks. Results showed statistically and clinically significant improvements in pain scores at Week 14. Participants receiving TONMYA also experienced greater reductions in symptom severity and improvements in physical functioning, as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQR), compared with placebo. Improvements in FIQR symptom and function scores were observed at Weeks 2, 6, 10 and 14 in both studies. Week 14 results were statistically significant for both domains in RESILIENT (p≤0.001) and nominally significant in RELIEF (p<0.01). TONMYA was generally well tolerated, with no new safety signals identified and local oral administration site reactions reported as the most common treatment-emergent adverse events.
CEO Seth Lederman said the findings reinforce the potential role of TONMYA as a first-line, non-opioid treatment option for adults with fibromyalgia. For a detailed view of the announcement, see the full press release.
Tonix Pharmaceuticals is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg) is the company’s recently approved flagship medicine and the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including acute migraine products Zembrace SymTouch and Tosymra. The company is also maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. Its CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. The company’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. The latest news and updates relating to TNXP are available in the company’s newsroom.
The data matters because fibromyalgia, a chronic condition affecting millions worldwide, has long lacked new treatment options, and the positive Phase 3 results position TONMYA as a potential first-line non-opioid therapy. If approved for broader use, it could offer patients an alternative to opioids amid the ongoing opioid crisis. The presentation at a major international pain congress may also raise awareness among clinicians and researchers, potentially accelerating adoption and further study. For investors, the results could bolster confidence in Tonix’s pipeline and commercial strategy. The announcement was distributed by BioMedWire, a specialized communications platform focused on biotechnology, biomedical sciences and life sciences. BioMedWire is one of 75+ brands within the Dynamic Brand Portfolio at IBN, which provides wire solutions via InvestorWire, editorial syndication to 5,000+ outlets, press release enhancement, social media distribution and tailored corporate communications solutions. Full terms of use and disclaimers are available on the BioMedWire website.
