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Tonix Pharmaceuticals Announces Publication of Steady-State Pharmacokinetics of TONMYA® After 20 Days of Daily Dosing in the Peer-Reviewed Journal, Clinical Pharmacology in Drug Development
TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime, is the first new FDA-approved treatment for fibromyalgia in adults in
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime, is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years TONMYA commercially launched in the U.S. in November 2025 BERKELEY HEIGHTS, N.J., April 15, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (\"Tonix\" or the \"Company\"), a fully-integrated, commercial stage biotechnology company, today announced the publication of a paper, \"Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial,\" in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology (ACCP). TONMYA® (cyclobenzaprine HCl sublingual tablets) was investigated under the designation TNX-102 SL. The manuscript can be accessed at https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.70060. \"TONMYA’s sublingual tablet was developed for long-term daily dosing at bedtime to target the nonrestorative sleep associated with fibromyalgia,\" said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Therefore, the steady-state pharmacokinetic (PK) profile at Day 20 is more relevant to the product’s indicated dosing regimen than single dose PK. The dynamic changes in cyclobenzaprine concentrations from sublingual tablet dosing over 24 hours at Day 20 are believed to provide pharmacodynamic effects on the brain owing to rapid absorption and distribution. The sublingual tablet was designed with a basifying ingredient and cyclobenzaprine–mannitol eutectic to provide transmucosal absorption to speed uptake, deliver maximum plasma levels of cyclobenzaprine during the middle of the sleep phase, and bypass first-pass liver metabolism. This study supported TONMYA's approval for the treatment of fibromyalgia in adults by the U.S. Food and Drug Administration (FDA) and elucidates how TONMYA’s pharmacokinetic profile is consistent with long-term daily dosing at bedtime.” Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The dynamic changes in cyclobenzaprine concentrations are magnified by the higher predicted percentage of receptors by cyclobenzaprine relative to norcyclobenzaprine occupied (...