A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants

TNX-102 SL has recently been approved by the United States (US) Food and Drug Administration (FDA) under the brand name TONMYA for the treatment of fibromyalgia. Fibromyalgia is a long-lasting condition that causes pain all over the body, along with feeling tired and not sleeping well. TNX-102 SL is not approved for any conditions in Canada. The study looks at the safety and blood levels of a study drug called TNX-102 SL \[cyclobenzaprine hydrochloride (HCl) sublingual (SL) tablets\], taken under the tongue, and compares it in non-elderly and elderly male and female participants.

NCT Number	NCT07413367
Lead Sponsor	Tonix Pharmaceuticals, Inc. Collaborators: Syneos Health
Conditions	Pharmakokinetic, Open Label, Phase 1
Enrollment	50 participants
Start Date	2025-12-09
Primary Completion	2026-02-10 (estimated)
Study Completion	2026-02-10 (estimated)
Updated on ClinicalTrials.gov	2026-02-17