Tonix Pharmaceuticals Holding Corp. presented clinical data for TONMYA at the 2026 Non-Opioid Pain Therapeutics Summit in Boston, revealing positive results from a Phase 3 trial for fibromyalgia treatment. The data came from the RESILIENT study, a 14-week randomized, double-blind, placebo-controlled trial involving 456 patients with fibromyalgia. Bedtime sublingual administration of TONMYA demonstrated a statistically significant reduction in weekly average pain scores at Week 14 compared to placebo, with a p-value of less than 0.0001.
The treatment also showed significant improvements in sleep disturbance, fatigue, and functional outcomes for patients. Tonix reported that TONMYA was well tolerated, with low discontinuation rates and primarily mild, self-limited adverse events. These findings support its potential as a differentiated, centrally acting non-opioid treatment designed to address both pain and non-restorative sleep in fibromyalgia patients.
TONMYA represents the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years, offering a critical alternative to opioid-based therapies. Fibromyalgia is a chronic pain condition affecting millions of adults, and the lack of new treatment options has been a significant challenge in pain management. The full press release detailing these findings is available at https://ibn.fm/VizLh.
Beyond fibromyalgia, Tonix has a diverse development portfolio focused on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases. The company markets two treatments for acute migraine in adults: Zembrace SymTouch and Tosymra. Their development pipeline includes TNX-102 SL for acute stress reaction and major depressive disorder, TNX-1500 for organ transplant rejection and autoimmune diseases, and TNX-2900 for Prader-Willi syndrome.
The company’s infectious disease research includes TNX-801 vaccine for mpox and smallpox, TNX-4800 for Lyme disease prevention, and TNX-4200, a broad-spectrum antiviral agent with U.S. Department of Defense funding. Tonix operates a state-of-the-art infectious disease research facility in Frederick, Maryland. Investors can find the latest news and updates relating to TNXP in the company’s newsroom at https://ibn.fm/TNXP.
The presentation of these Phase 3 results marks a significant advancement in non-opioid pain management, particularly for fibromyalgia patients who have had limited treatment options. The data suggests TONMYA could provide comprehensive relief by addressing both pain and sleep disturbances, which are hallmark symptoms of the condition. As chronic pain continues to be a major public health concern, with opioid misuse remaining problematic, non-opioid alternatives like TONMYA represent an important development in patient care and pain management strategies.
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