Curated News
By: NewsRamp Editorial Staff
January 30, 2026
Tonix's TONMYA Shows Breakthrough Results in Fibromyalgia Pain & Sleep
TLDR
- Tonix Pharmaceuticals' TONMYA offers a competitive edge as a first-in-class non-opioid fibromyalgia treatment with proven pain reduction and sleep improvement in Phase 3 trials.
- TONMYA demonstrated statistically significant pain reduction and functional improvements in a 14-week Phase 3 trial with 456 fibromyalgia patients using bedtime sublingual administration.
- This non-opioid treatment improves quality of life for fibromyalgia patients by addressing both chronic pain and sleep disturbances with minimal side effects.
- TONMYA represents the first new FDA-approved fibromyalgia medicine in over 15 years, showing promise beyond pain relief to enhance sleep and daily function.
Impact - Why it Matters
This development represents a significant advancement in chronic pain management, particularly for the estimated 4 million American adults suffering from fibromyalgia who have had limited treatment options. The approval of TONMYA marks the first new FDA-approved fibromyalgia medication in over 15 years, addressing a critical unmet medical need. Beyond immediate patient impact, this breakthrough demonstrates the viability of non-opioid pain therapeutics at a time when the opioid crisis continues to devastate communities. The treatment's dual action on both pain and sleep disturbance addresses core symptoms that significantly impair quality of life for fibromyalgia patients. For investors, Tonix's diverse pipeline across CNS disorders, immunology, and infectious diseases, including government-funded projects, suggests substantial growth potential in multiple therapeutic areas.
Summary
Tonix Pharmaceuticals (NASDAQ: TNXP) has unveiled promising clinical data for its fibromyalgia treatment TONMYA™ at the 2026 Non-Opioid Pain Therapeutics Summit in Boston. The data, drawn from the RESILIENT Phase 3 trial involving 456 patients, showed that bedtime sublingual administration of TONMYA achieved a statistically significant reduction in weekly average pain scores compared to placebo (p<0.0001) at Week 14. Beyond pain relief, the treatment demonstrated significant improvements in sleep disturbance, fatigue, and functional outcomes, positioning it as a differentiated, centrally acting non-opioid therapy designed to address both pain and non-restorative sleep in fibromyalgia patients. The company reported that TONMYA was well tolerated with low discontinuation rates and primarily mild, self-limited adverse events, supporting its potential as a breakthrough treatment for this chronic condition.
Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company that markets FDA-approved TONMYA™, the first new prescription medicine approved for fibromyalgia in over 15 years, along with two acute migraine treatments: Zembrace® SymTouch® and Tosymra®. The company's extensive development portfolio spans central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases, including TNX-102 SL for acute stress reaction and major depressive disorder, TNX-1500 for organ transplant rejection and autoimmune diseases, TNX-2900 for Prader-Willi syndrome, TNX-801 for mpox and smallpox, TNX-4800 for Lyme disease prevention, and TNX-4200 for broad-spectrum antiviral applications under a U.S. Department of Defense contract worth up to $34 million. Tonix operates a state-of-the-art infectious disease research facility in Frederick, Maryland, and maintains a comprehensive corporate communications platform through its partnership with TinyGems, which is part of the Dynamic Brand Portfolio at IBN, providing extensive media distribution and investor outreach capabilities.
The news release was distributed through TinyGems, a specialized communications platform within the Investor Brand Network's Dynamic Brand Portfolio that focuses on innovative small-cap and mid-cap companies. TinyGems offers comprehensive corporate communications solutions including wire distribution through InvestorWire, editorial syndication to over 5,000 outlets, enhanced press release services, social media distribution to millions of followers, and tailored communications strategies. This platform helps companies like Tonix Pharmaceuticals reach a wide audience of investors, influencers, consumers, and journalists, providing unparalleled recognition and brand awareness in today's crowded market. For more information about Tonix's latest developments, investors can access the company's newsroom or visit the TinyGems website for comprehensive coverage of emerging companies with significant growth potential.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Tonix's TONMYA Shows Breakthrough Results in Fibromyalgia Pain & Sleep
