Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented new Phase 3 data showing that its flagship medicine TONMYA(R) (cyclobenzaprine HCl sublingual tablets) improved physical symptoms and functional capacity in adults with fibromyalgia. The findings, from the RELIEF and RESILIENT studies, were shared at the International Association for the Study of Pain 2026 World Congress on Pain, held October 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; local oral administration site reactions were 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. The data matters because fibromyalgia, a chronic condition characterized by widespread pain and fatigue, has seen few new treatment options in recent years. TONMYA, approved as a sublingual tablet, is the first new treatment for fibromyalgia in more than 15 years, according to the company. If the Phase 3 results hold up, TONMYA could offer patients an alternative to opioids and other existing therapies, addressing a significant unmet need in pain management.
Tonix is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments. Beyond TONMYA, its CNS commercial infrastructure supports marketed acute migraine products Zembrace(R) SymTouch(R) and Tosymra(R). The company is also maximizing the science behind TONMYA in Phase 2 trials for major depressive disorder and acute stress disorder, and is advancing TNX-2900 for Prader-Willi syndrome, TNX-4800 for Lyme disease prophylaxis, and TNX-1500 for kidney transplant rejection prevention. For investors, the latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP.
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