NDAORALCAPSULE, EXTENDED RELEASE
Approved
Feb 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
AMRIX (cyclobenzaprine hydrochloride) by Teva is function. First approved in 2007.
Drug data last refreshed 21h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMRIX is an extended-release oral capsule formulation of cyclobenzaprine hydrochloride, a centrally acting skeletal muscle relaxant approved in 2007. It reduces muscle spasm by decreasing tonic somatic motor activity at the brainstem level, with effects on both gamma and alpha motor systems. AMRIX is used for acute muscle spasm relief and is structurally related to tricyclic antidepressants, producing sedation and anticholinergic effects.
$0.577MPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Medicare Part D activity (202 claims in 2023), suggesting a mature, niche product with limited team expansion opportunities.
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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.