Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced two oral presentations on TONMYA (investigated as TNX-102 SL) at the 8th International Congress on Controversies in Fibromyalgia held March 9-10, 2026, in Krakow, Poland. The presentations highlighted post hoc analyses from the Phase 3 RESILIENT trial and pooled data from the RELIEF and RESILIENT studies, emphasizing rapid pain relief and a favorable benefit-risk profile for TONMYA in adults with fibromyalgia.
The data showed statistically significant reductions in pain and a likelihood of clinical benefit nearly four times greater than discontinuation due to adverse events. TONMYA, the first medication approved for fibromyalgia in more than 15 years, was generally well tolerated, with mild and transient oral cavity reactions reported as the most common adverse events. These findings underscore the potential of TONMYA as a valuable treatment option for patients suffering from fibromyalgia, a condition characterized by chronic widespread pain and often accompanied by fatigue, sleep disturbances, and cognitive issues.
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg) is the company’s recently approved flagship medicine. The company’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace SymTouch and Tosymra. Tonix is also maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. Additionally, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.
The full press release is available at https://ibn.fm/hv3Cl. For more information about Tonix Pharmaceuticals, visit their newsroom at https://ibn.fm/TNXP.
The presentations at the International Fibromyalgia Congress provide important insights into the efficacy and safety of TONMYA, reinforcing its role as a significant advancement in fibromyalgia treatment. The positive benefit-risk profile demonstrated in the analyses may encourage broader adoption among clinicians and patients seeking effective management options for this challenging condition.
