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Tonix Pharmaceuticals Announces Publication of Clinical Pharmacokinetic Studies of TONMYA™ and Prototype Formulations in the Journal Clinical Pharmacology in Drug Development
Commercially launched in the U.S. in November 2025, TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime is the first new
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Commercially launched in the U.S. in November 2025, 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 The sublingual TONMYA tablet containing a basifying agent achieved the design objectives of rapid transmucosal absorption and bypassing first-pass liver metabolism TONMYA was designed to decrease production of the active metabolite norcyclobenzaprine, which is believed to improve the durability of analgesic response in fibromyalgia relative to the transient (~1 month) effects of oral, swallowed cyclobenzaprine BERKELEY HEIGHTS, N.J., March 05, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced the publication of a paper, “Single-Dose Pharmacokinetic Assessment of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open-Label Studies in Healthy Volunteers,” in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology (ACCP). TONMYA™ was investigated as TNX-102 SL (cyclobenzaprine HCl sublingual tablets) and approved by the U.S. Food and Drug Administration (FDA) on August 15, 2025, for the treatment of fibromyalgia in adults. The manuscript can be accessed at: https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.70034. \"These data demonstrate the importance of the proprietary basifying agent in TONMYA's sublingual formulation,\" said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. \"An earlier study conducted by Tonix showed that transmucosal delivery cannot be achieved by simply applying a liquid cyclobenzaprine HCl formulation under the tongue. Due to the basifying agent ingredient, sublingual TONMYA achieves rapid transmucosal absorption that bypasses first-pass hepatic metabolism. This pharmacokinetic profile underpins TONMYA's unique sublingual formulation, which is designed to increase parent drug exposure during sleep while reducing exposure and side effects to the long half-life, active metabolite.” Dr. Lederman continued, “Bedtime oral swallowed cyclobenzaprine was one of the first drugs studied as a treatment for fibromyalgia, but it failed because the benefits were ...