Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented Phase 3 data at the International Association for the Study of Pain 2026 World Congress on Pain, held Oct. 26-30 in Bangkok, Thailand, showing that its newly approved fibromyalgia treatment TONMYA (cyclobenzaprine HCl sublingual tablets) significantly improved physical symptoms and functional capacity in adults with the condition. The results, detailed in a recent announcement from BioMedWire, come from the randomized, double-blind, placebo-controlled RELIEF and RESILIENT trials, which evaluated TONMYA against placebo over 14 weeks.
Both studies demonstrated 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 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 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 company notes that TONMYA is the first new treatment for fibromyalgia in more than 15 years, underscoring the significance of these results for a condition that has long lacked innovative therapies.
Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, and cognitive difficulties, affecting millions of adults worldwide. The availability of a new, well-tolerated non-opioid option could meaningfully change the treatment landscape, particularly given ongoing concerns about opioid dependence. Tonix’s CNS commercial infrastructure already supports marketed products for acute migraine, and the company is maximizing the science behind TONMYA in Phase 2 trials for major depressive disorder and acute stress disorder, potentially expanding its reach.
For investors, the data presentation may bolster confidence in TONMYA’s commercial prospects. Tonix is a fully integrated, commercial-stage biopharmaceutical company focused on central nervous system and immunology treatments. Its pipeline includes TNX-2900 for Prader-Willi syndrome and immunology candidates TNX-4800 for Lyme disease prophylaxis and TNX-1500 for kidney transplant rejection prevention. The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP. To view the full press release, visit https://ibn.fm/8D8UV.
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