Tonix Pharmaceuticals Announces Peer-Reviewed Publication on TONMYA Pharmacokinetics

Tonix Pharmaceuticals Holding Corp. announced the publication of a peer-reviewed paper detailing results from randomized open-label studies evaluating the pharmacokinetics of TNX-102 SL, the sublingual formulation of cyclobenzaprine HCl marketed as TONMYA. Published in Clinical Pharmacology in Drug Development, the journal of the American College of Clinical Pharmacology, the study highlights how TONMYA's proprietary basifying agent enables rapid transmucosal absorption that bypasses first-pass hepatic metabolism. The formulation, approved by the U.S. Food and Drug Administration on Aug. 15, 2025, for the treatment of fibromyalgia in adults, is designed to increase parent drug exposure during sleep while reducing exposure to the long-acting metabolite norcyclobenzaprine, supporting durable analgesic benefits with improved tolerability.

TONMYA represents the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years, addressing a chronic pain condition that affects millions of adults. The pharmacokinetic findings are significant because they demonstrate how the sublingual delivery system fundamentally alters drug metabolism compared to oral formulations. By bypassing first-pass hepatic metabolism through transmucosal absorption, TONMYA achieves higher concentrations of the active parent drug while minimizing production of norcyclobenzaprine, which has been associated with next-day sedation and other tolerability issues in traditional oral formulations.

The research publication provides scientific validation for TONMYA's mechanism of action, which is particularly important given that fibromyalgia treatment has seen limited innovation in recent years. The study's findings in Clinical Pharmacology in Drug Development offer clinicians and researchers detailed pharmacokinetic data supporting TONMYA's clinical profile. This peer-reviewed validation comes at a critical time as healthcare providers seek non-opioid alternatives for chronic pain management, especially for conditions like fibromyalgia that require long-term treatment strategies.

Beyond fibromyalgia, Tonix is developing TNX-102 SL for other central nervous system disorders, including acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense. The company's broader development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, rare disease and infectious disease. Tonix's state-of-the-art infectious disease research facility in Frederick, Maryland supports these development efforts across multiple therapeutic areas.

The pharmacokinetic data published in Clinical Pharmacology in Drug Development provides important insights into how formulation science can optimize drug delivery for improved therapeutic outcomes. For fibromyalgia patients who have had limited treatment options, TONMYA's approval and the supporting pharmacokinetic research represent meaningful progress in pain management. The study's findings about reduced metabolite exposure while maintaining analgesic efficacy address key concerns about tolerability and safety in chronic pain treatment, potentially offering patients a more sustainable long-term management option for this challenging condition.