Tonix Pharmaceuticals Publishes Pharmacokinetic Study for Fibromyalgia Treatment TONMYA in Clinical Pharmacology Journal

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the publication of a peer-reviewed study detailing the steady-state pharmacokinetic properties of TNX-102 SL, the sublingual formulation of cyclobenzaprine HCl marketed as TONMYA(R), in Clinical Pharmacology in Drug Development. The study, conducted in 60 healthy volunteers, demonstrated that the sublingual formulation achieves faster absorption, earlier peak plasma concentration and higher dose-normalized bioavailability compared to oral extended-release cyclobenzaprine, supporting its use for long-term bedtime dosing to target nonrestorative sleep in fibromyalgia, reduce pain and improve related symptoms.

This publication represents significant validation for Tonix's approach to fibromyalgia treatment, particularly as TONMYA(TM) (cyclobenzaprine HCl sublingual tablets 2.8mg) is the first new treatment for fibromyalgia in more than 15 years. The pharmacokinetic advantages demonstrated in the study could translate to improved patient outcomes for the estimated 6-12 million Americans affected by fibromyalgia, a chronic condition characterized by widespread pain, fatigue, and sleep disturbances. The faster absorption profile of the sublingual formulation may allow for more rapid onset of therapeutic effects when taken at bedtime, potentially addressing the nonrestorative sleep patterns that exacerbate fibromyalgia symptoms.

The study's findings support Tonix's broader development strategy for TONMYA, which includes Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. As a commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need, Tonix is leveraging this pharmacokinetic data to maximize the scientific foundation of its flagship product. The company's CNS commercial infrastructure already supports marketed products including acute migraine treatments Zembrace(R) SymTouch(R) and Tosymra(R), positioning Tonix to effectively commercialize TONMYA for fibromyalgia patients.

Beyond TONMYA, Tonix is 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 company's CNS portfolio also includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. These development candidates remain investigational new drugs or biologics whose efficacy and safety have not been established. The publication of the TONMYA pharmacokinetic study in a peer-reviewed journal represents an important milestone in validating the scientific approach behind Tonix's lead product while supporting its potential expansion into additional indications where improved sleep and pain management could provide therapeutic benefits.