Tonix Pharmaceuticals announced the publication of clinical pharmacokinetic studies for TONMYA, a sublingual cyclobenzaprine HCl tablet formulation in the Journal Clinical Pharmacology in Drug Development. TONMYA was approved by the FDA on August 15, 2025, for the treatment of fibromyalgia in adults and is the first new FDA-approved treatment for fibromyalgia in more than 15 years. The drug was commercially launched in the United States in November 2025.
The publication reports findings from two Phase 1 studies conducted in healthy adult volunteers. In the first study with 24 participants, three sublingual formulations of cyclobenzaprine HCl 2.8 mg containing different basifying agents were compared with oral immediate-release cyclobenzaprine HCl 5 mg. All sublingual formulations showed rapid absorption and increased relative bioavailability compared with oral formulations. The potassium phosphate dibasic formulation demonstrated the most favorable profile, with 154 percent relative bioavailability compared to oral immediate-release, an absorption lag of approximately 3 minutes versus approximately 37 minutes for oral formulation, and 783 percent higher dose-normalized AUC during the first hour post-dose.
In the second study with 16 participants, TNX-102 SL was evaluated in crossover design at 2.8 mg and 5.6 mg under fasting and fed conditions. The formulation showed dose proportionality between the two dose levels, and pharmacokinetic parameters were not affected by high-calorie, high-fat meals. The active metabolite norcyclobenzaprine demonstrated an elimination half-life of approximately 60 hours. Reduced exposure to norcyclobenzaprine following sublingual administration is believed to contribute to improved durability of efficacy observed with TONMYA. The sublingual formulation was generally well tolerated, with most commonly reported adverse events being oral hypoesthesia and abnormal taste, both mild to moderate in severity. No serious adverse events were reported.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.globenewswire.com/news-release/2026/03/05/3250690/28908/en/Tonix-Pharmaceuticals-Announces-Publication-of-Clinical-Pharmacokinetic-Studies-of-TONMYA-and-Prototype-Formulations-in-the-Journal-Clinical-Pharmacology-in-Drug-Development.html