Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced two oral presentations on TONMYA (investigated as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) at the 8th International Congress on Controversies in Fibromyalgia held March 9-10, 2026, in Krakow, Poland. The presentations featured post hoc analyses from the Phase 3 RESILIENT trial and pooled data from the RELIEF and RESILIENT studies, highlighting rapid pain relief and a favorable benefit-risk profile for TONMYA in adults with fibromyalgia.
The data demonstrated 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 new treatment option for the millions of patients suffering from fibromyalgia, a condition characterized by chronic widespread pain and often accompanied by fatigue, sleep disturbances, and mood 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), the company’s recently approved flagship medicine, represents a significant advancement in fibromyalgia management. The company’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace SymTouch and Tosymra. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder.
Additionally, Tonix’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. The company 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. These developments highlight Tonix’s commitment to addressing conditions with significant unmet medical needs.
The full press release is available at https://ibn.fm/hv3Cl. For more information about Tonix Pharmaceuticals, visit the company’s newsroom at https://ibn.fm/TNXP. The data presented at the congress not only reinforce the efficacy and safety of TONMYA but also provide valuable insights for clinicians treating fibromyalgia. This is particularly important given the limited treatment options available for this condition over the past decade and a half.
