Tonix Pharmaceuticals (NASDAQ: TNXP), a commercial-stage biopharmaceutical company, presented data from its Phase 3 RELIEF and RESILIENT studies demonstrating that TONMYA(R) (cyclobenzaprine HCl sublingual tablets) improved physical symptoms and functional capacity in adults with fibromyalgia. The findings were presented at the International Association for the Study of Pain 2026 World Congress on Pain, held Oct. 26-30 in Bangkok, Thailand. Both randomized, double-blind, placebo-controlled trials evaluated TONMYA against placebo over 14 weeks, with results showing statistically and clinically significant improvements in pain scores at Week 14. Participants receiving TONMYA also experienced greater reductions in symptom severity and improvements in physical functioning, as measured by the Fibromyalgia Impact Questionnaire-Revised (“FIQR”), compared with placebo.
Improvements in FIQR symptom and function scores were observed at Weeks 2, 6, 10 and 14 in both studies. Week 14 results were statistically significant for both domains in RESILIENT (p≤0.001) and nominally significant in RELIEF (p<0.01). TONMYA was generally well tolerated, with no new safety signals identified and local oral administration site reactions reported as the most common treatment-emergent adverse events. CEO Seth Lederman said the findings reinforce the potential role of TONMYA as a first-line, non-opioid treatment option for adults with fibromyalgia.
To view the full press release, visit https://ibn.fm/OsQFy
Tonix Pharmaceuticals Holding Corp.
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(TM) (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace(R) SymTouch(R) and Tosymra(R). Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, 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.
* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP
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