Curated News
By: NewsRamp Editorial Staff
October 27, 2026
Tonix's TONMYA Shows Promise in Fibromyalgia Trials
TLDR
- Tonix's TONMYA data position it as the first new fibromyalgia treatment in over 15 years and a first-line non-opioid option.
- Two randomized, double-blind, placebo-controlled 14-week trials showed significant pain and function improvements via FIQR scores.
- Tonix's TONMYA offers fibromyalgia patients a well-tolerated, non-opioid option that improves daily physical function and symptom relief.
- Tonix presented Phase 3 TONMYA fibromyalgia data at the IASP 2026 World Congress on Pain in Bangkok, Thailand.
Impact - Why it Matters
Fibromyalgia affects millions worldwide, yet treatment options have remained limited for over 15 years. The positive Phase 3 data for TONMYA suggest a potential first-line, non-opioid therapy that could significantly improve pain management and daily functioning for patients. With its recent approval, TONMYA may offer a much-needed alternative to existing treatments, addressing a critical unmet need in pain management. For investors, these results bolster confidence in Tonix's flagship product and its broader pipeline, positioning the company for growth in the CNS and immunology space.
Summary
Tonix Pharmaceuticals (NASDAQ: TNXP), a commercial-stage biopharmaceutical company, presented new data from its Phase 3 RELIEF and RESILIENT studies at the International Association for the Study of Pain 2026 World Congress on Pain in Bangkok. The trials evaluated TONMYA® (cyclobenzaprine HCl sublingual tablets) in adults with fibromyalgia and demonstrated statistically and clinically significant improvements in pain scores at Week 14, along with greater reductions in symptom severity and improved physical functioning compared to placebo, as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQR).
Improvements in FIQR symptom and function scores were observed at Weeks 2, 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; local oral administration site reactions were the most common treatment-emergent adverse events. CEO Seth Lederman said the findings reinforce TONMYA’s potential as a first-line, non-opioid treatment option for fibromyalgia. For the full press release, visit https://ibn.fm/8D8UV. Tonix is a fully-integrated biotechnology company focused on central nervous system and immunology treatments, with TONMYA being the first new fibromyalgia treatment in over 15 years. The company also markets acute migraine products and is advancing a pipeline that 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 updates are available in the company’s newsroom at https://ibn.fm/TNXP.
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Source Statement
This curated news summary relied on content distributed by InvestorBrandNetwork (IBN). Read the original source here, Tonix's TONMYA Shows Promise in Fibromyalgia Trials
