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 research published in Clinical Pharmacology in Drug Development provides scientific validation for TONMYA's mechanism of action, which represents a significant advancement in non-opioid pain management. By bypassing first-pass hepatic metabolism through sublingual administration, the formulation achieves therapeutic effects while potentially reducing side effects associated with traditional oral medications. This approach could establish new standards for drug delivery in chronic pain conditions where tolerability and safety are critical concerns.
Tonix Pharmaceuticals maintains a comprehensive development portfolio focused on central nervous system disorders, immunology, immuno-oncology, rare disease and infectious disease. The company's research initiatives include TNX-102 SL being developed to treat 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. Additional development programs include TNX-1500 for organ transplant rejection and autoimmune diseases, TNX-2900 for Prader-Willi syndrome, TNX-801 for mpox and smallpox prevention, and TNX-4800 for seasonal prevention of Lyme disease.
The publication of this pharmacokinetic data in a peer-reviewed journal represents an important milestone for both Tonix Pharmaceuticals and the broader fibromyalgia treatment landscape. For patients suffering from this chronic condition, the availability of a new non-opioid treatment option with demonstrated pharmacokinetic advantages could translate to improved quality of life and better management of symptoms. For the pharmaceutical industry, TONMYA's approval and supporting research demonstrate continued innovation in drug delivery systems and formulation science.
Tonix's state-of-the-art infectious disease research facility in Frederick, Maryland supports the company's broader research initiatives, including work on TNX-4200, for which Tonix has a contract with the U.S. DoD's Defense Threat Reduction Agency for up to $34 million over five years. This small molecule broad-spectrum antiviral agent targets CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments.
The latest news and updates relating to Tonix Pharmaceuticals are available in the company's newsroom at https://ibn.fm/TNXP. The full press release detailing the pharmacokinetic publication can be viewed at https://ibn.fm/8zoXF. BioMedWire, which distributed the original announcement, provides specialized communications services for the biotechnology and life sciences sectors through its platform at https://www.BioMedWire.com.
