AMRIX (cyclobenzaprine hydrochloride)
Amrix helps patients with muscle spasms caused by sudden, painful musculoskeletal conditions. It is used as an addition to rest and physical therapy to help improve pain, tenderness, and physical movement. This medication is intended for short-term use, typically up to three weeks, as these types of muscle issues usually resolve quickly. It is not used for spasms caused by central nervous system diseases like cerebral palsy.
How AMRIX Works
This medication works by acting primarily on the brain stem within the central nervous system to reduce tonic motor activity. It targets the alpha and gamma motor systems to relieve spasms without directly affecting muscle tissue or interfering with normal muscle function. Its effects are similar to those of tricyclic antidepressants, influencing the nervous system to decrease skeletal muscle hyperactivity.
Details
- Status
- Prescription
- First Approved
- 2007-02-01
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
AMRIX Approval History
What AMRIX Treats
2 indicationsAMRIX is approved for 2 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Muscle Spasm
- Musculoskeletal Condition
AMRIX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01151787 | CEPH03242010 | Ph 3 | terminated | Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMRIX FDA Label Details
Indications & Usage
FDA Label (PDF)AMRIX is indicated for the treatment of Muscle Spasm; Musculoskeletal Condition.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.