Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) presented new Phase 3 data at the International Association for the Study of Pain 2026 World Congress on Pain, showing that TONMYA(R) (cyclobenzaprine HCl sublingual tablets) significantly improved physical symptoms and functional capacity in adults with fibromyalgia. The results, from the RELIEF and RESILIENT studies, 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 statistically and clinically significant improvements in pain scores at Week 14, along with greater reductions in symptom severity and better physical functioning 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 identified. The most common treatment-emergent adverse events were local oral administration site reactions. CEO Seth Lederman said the findings reinforce the potential role of TONMYA as a first-line, non-opioid treatment option for adults with fibromyalgia. This is particularly important given the ongoing opioid crisis and the limited effective alternatives for chronic pain management.
Fibromyalgia affects millions of adults worldwide, causing widespread pain, fatigue, and cognitive difficulties that severely impact quality of life. The lack of new therapies in over a decade has left patients and clinicians with few options. TONMYA, if approved, could fill a critical gap by offering a non-addictive, sublingual treatment that targets both pain and functional impairment. The positive Phase 3 data may also bolster Tonix's commercial strategy, as the company continues to advance its central nervous system portfolio, including programs in major depressive disorder and acute stress disorder.
For investors, the data presentation at a major international pain congress adds visibility and credibility to Tonix's flagship product. The company's fully integrated commercial infrastructure and its recent approval of TONMYA as the first new fibromyalgia treatment in more than 15 years position it for potential market uptake. Further details can be found in the full press release available at https://ibn.fm/8D8UV, and ongoing updates are available in the company's newsroom at https://ibn.fm/TNXP.
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