Tonix Pharmaceuticals Presented an Analysis of Phase 3 Data Demonstrating TONMYA® Improved Physical Symptoms and Functional Ability of Patients with Fibromyalgia at the IASP 2026 World Congress on Pain
Globe Newswire•27/10/2026•07:00 ET
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Key Highlights
- ➤Week 14 FIQR Symptoms and Function scores significantly improved versus placebo in both Phase 3 studies
- ➤RESILIENT Week 14 results statistically significant for both FIQR domains, p≤0.001
- ➤RELIEF Week 14 results nominally significant for both FIQR domains, p<0.01
- ➤TONMYA commercially launched in November 2025 after FDA approval for adult fibromyalgia
- ➤TONMYA generally well tolerated; no new safety signals observed
Expert Statements
Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals
“TONMYA improved a broad spectrum of physical symptoms and functional capacity in adults with fibromyalgia in two Phase 3 studies.”
Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals
“The core physical symptoms of fibromyalgia can be debilitating for patients with fibromyalgia, interfering with their quality of life.”
Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals
“We believe the data reinforce the role of TONMYA as a first-line, non-opioid treatment option that can help patients function better in their daily lives.”
TONMYA improved Fibromyalgia Impact Questionnaire-Revised (FIQR) symptoms and function scores versus placebo in both domains at Week 14 in RELIEF and RESILIENT Phase 3 pivotal studies
Tonix commercially launched TONMYA(®) in November 2025, the first fibromyalgia drug for adults in the U.S. in over 15 years approved by the U.S. Food and Drug Administration (FDA)
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