Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented data from its Phase 3 RELIEF and RESILIENT studies at the International Association for the Study of Pain 2026 World Congress on Pain, showing that TONMYA (cyclobenzaprine HCl sublingual tablets) improved physical symptoms and functional capacity in adults with fibromyalgia. The results, which were statistically and clinically significant for pain reduction and functional improvement, highlight the drug's potential to address a major unmet need in a condition that has lacked new treatment options for over 15 years.
The two randomized, double-blind, placebo-controlled trials evaluated TONMYA over 14 weeks. Participants receiving TONMYA experienced greater reductions in symptom severity and improvements in physical functioning compared with placebo, as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQR). Improvements in FIQR symptom and function scores were observed as early as Week 2 and sustained through Weeks 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 and local oral administration site reactions being the most common treatment-emergent adverse events.
The implications are substantial. Fibromyalgia affects millions worldwide, causing chronic widespread pain, fatigue, and cognitive difficulties, and current treatments often rely on opioids despite their risks. TONMYA's non-opioid profile and sublingual formulation could offer a safer, more convenient first-line option. 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 company's press release is available at https://ibn.fm/8D8UV, and ongoing updates can be found in the company's newsroom at https://ibn.fm/TNXP.
Tonix is a fully-integrated, commercial-stage biotechnology company focused on central nervous system and immunology treatments. TONMYA, its recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. The company is also maximizing the science behind TONMYA in Phase 2 trials for major depressive disorder and acute stress disorder, and advancing a pipeline that includes TNX-2900 for Prader-Willi syndrome, TNX-4800 for Lyme disease prophylaxis, and TNX-1500 for kidney transplant rejection prevention. For investors, the positive Phase 3 data could bolster confidence in TONMYA's commercial trajectory and Tonix's broader CNS portfolio.
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