Tonix Pharmaceuticals Reports Positive Phase 3 Results for TONMYA in Fibromyalgia Treatment

Tonix Pharmaceuticals Holding Corp. announced the presentation of clinical data for TONMYA at the 2026 Non-Opioid Pain Therapeutics Summit in Boston. The data originated from the RESILIENT trial, a 14-week Phase 3 randomized, double-blind, placebo-controlled study involving 456 fibromyalgia patients. Results demonstrated that bedtime sublingual administration of TONMYA achieved 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.

The company reported that TONMYA was well tolerated during the trial, exhibiting low discontinuation rates and primarily mild, self-limited adverse events. These findings support TONMYA's potential as a differentiated, centrally acting non-opioid treatment designed to address both pain and non-restorative sleep in fibromyalgia patients. Tonix markets TONMYA as a first-in-class, non-opioid analgesic medicine for fibromyalgia, which represents the first new prescription medicine approved by the FDA for this condition in over 15 years. Previously investigated as TNX-102 SL, TONMYA's approval and these positive trial results highlight its role in managing a chronic pain condition affecting millions of adults.

Tonix's broader development portfolio extends beyond fibromyalgia, focusing on central nervous system disorders, immunology, immuno-oncology, rare disease, and infectious disease. The company is developing TNX-102 SL for acute stress reaction and acute stress disorder through an Investigator-Initiated IND at the University of North Carolina in the OASIS study, funded by the U.S. Department of Defense. Additional developments include TNX-102 SL for major depressive disorder, TNX-1500 for preventing allograft rejection and treating autoimmune diseases, and TNX-2900 for Prader-Willi syndrome. The infectious disease portfolio features TNX-801 for mpox and smallpox, TNX-4800 for seasonal prevention of Lyme disease, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years from the Defense Threat Reduction Agency.

For more details on the company's developments, visit https://ibn.fm/TNXP. Tonix operates a state-of-the-art infectious disease research facility in Frederick, Maryland, supporting its diverse pipeline. All product development candidates remain investigational new drugs or biologics, with their efficacy and safety not yet established for any indication beyond approved uses. The presentation of these Phase 3 data at the summit underscores the ongoing innovation in non-opioid pain therapeutics, addressing critical needs in chronic pain management without relying on opioid-based treatments.