Tonix Pharmaceuticals Publishes TNX-102 SL Clinical Study Results

Tonix Pharmaceuticals announced the publication of a paper in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology. Tonmya was investigated as TNX-102 SL and approved by the FDA on August 15, 2025, for the treatment of fibromyalgia in adults. The publication reports findings from two Phase 1 single-dose, open-label studies conducted in healthy adult volunteers. In Study 1, three sublingual formulations of cyclobenzaprine HCl 2.8 mg, each containing a different basifying agent, were compared with oral immediate-release cyclobenzaprine HCl 5 mg under fasting conditions. All sublingual formulations showed rapid absorption and increased relative bioavailability compared with oral IR cyclobenzaprine HCl. The potassium phosphate dibasic formulation demonstrated the most favorable pharmacokinetic profile, with a 154% relative bioavailability compared to oral IR, an absorption lag of approximately three minutes versus approximately 37 minutes for oral IR, and a 783% higher dose-normalized AUC during the first hour post-dose. Based on these results, the potassium phosphate dibasic formulation was selected for further clinical development. In Study 2, TNX-102 SL 2.8 mg and 5.6 mg were evaluated in a crossover design under fasting and fed conditions. The formulation exhibited dose proportionality between the two dose levels, and pharmacokinetic parameters were not affected by a high-calorie, high-fat meal, confirming the absence of a food effect. This study also provided a full clinical characterization of the active metabolite norcyclobenzaprine, demonstrating an elimination half-life of approximately 60 hours. Reduced exposure to norcyclobenzaprine following sublingual administration, as compared with oral delivery, is believed to contribute to the improved durability of efficacy and favorable tolerability profile observed with TONMYA in Phase 3 fibromyalgia studies.Across both studies, single-dose sublingual cyclobenzaprine HCl was generally well tolerated. All treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse events were oral hypoesthesia and abnormal taste. No serious adverse events were reported, and no clinically meaningful changes were observed in laboratory parameters, vital signs, or electrocardiogram findings.