NDAORALCAPSULE, EXTENDED RELEASE
Approved
Feb 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Mechanism of Action
function. Cyclobenzaprine has not been shown to be effective in muscle spasm due to central nervous system disease. In animal models, cyclobenzaprine reduced or abolished skeletal muscle hyperactivity. Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or…
Clinical Trials (3)
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
Started Dec 2025
50 enrolled
PharmakokineticOpen LabelPhase 1
Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules
Started Jan 2018
60 enrolled
Healthy Subjects
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
Started Jul 2010
35 enrolled
Chronic Migraine