By VETTAPHARMA reporter: Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) presented new Phase 3 RESILIENT trial data on TONMYA™ (investigated as TNX-102 SL) at the 2026 Non-Opioid Pain Therapeutics Summit in Boston, Massachusetts. The data show that TONMYA, a centrally acting, non-opioid analgesic, produced statistically significant reduction in fibromyalgia pain compared to placebo in a large randomized study.
The RESILIENT study was a 14-week randomized, double-blind, placebo-controlled Phase 3 trial conducted at 34 US sites, enrolling 456 participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Participants received TONMYA or placebo administered sublingually at bedtime.
At Week 14, TONMYA demonstrated a statistically significant reduction in weekly average pain scores versus placebo (p < 0.0001) with an effect size of 0.38, indicating a meaningful clinical benefit for people with fibromyalgia. In addition to pain relief, TONMYA showed significant improvements in key secondary endpoints, including sleep disturbance (p < 0.001), fatigue (p < 0.001), and both the Symptoms and Function domains of the Fibromyalgia Impact Questionnaire-Revised (p < 0.001).
Treatment with TONMYA was generally well tolerated, with minimal effects on weight or blood pressure. The rate of adverse event-related discontinuations was 6.1% for TONMYA compared with 3.5% for placebo, and the most common adverse reactions were mild, self-limited oral cavity reactions that rarely led to study withdrawal.
TONMYA features a unique sublingual formulation designed for bedtime administration that bypasses first-pass metabolism. This approach aims to optimize exposure to the parent drug during sleep — a period relevant to fibromyalgia pathophysiology — while limiting daytime exposure to its active metabolite, potentially reducing undesired effects.
According to Tonix’s presentation, fibromyalgia affects more than 10 million adults in the U.S., a chronic pain disorder often treated with opioid-based or other therapies that may have limited efficacy or tolerability. TONMYA’s non-opioid profile and demonstrated broad-spectrum activity across core symptoms, including pain, sleep disturbance, and fatigue, may offer a differentiated treatment option for patients.
The company noted that TONMYA was approved by the US Food and Drug Administration on August 15, 2025 as the first new prescription medicine for fibromyalgia in more than 15 years, and is marketed as a non-opioid analgesic for adults.
Source credit:
- Tonix Pharmaceuticals Holding Corp. (2026, January 30). Tonix Pharmaceuticals presented Phase 3 RESILIENT data on TONMYA™ (cyclobenzaprine HCl sublingual tablets) at the 2026 Non-Opioid Pain Therapeutics Summit. Click here
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