STALEVO 125
Stalevo 125 is a combination of levodopa (an aromatic amino acid), carbidopa (an aromatic amino acid decarboxylation inhibitor), and entacapone (a catechol-O-methyltransferase [COMT] inhibitor). It is indicated for the treatment of patients with Parkinson's disease to replace carbidopa/levodopa and entacapone therapy previously administered as separate tablets, or to substitute for carbidopa/levodopa therapy in patients experiencing end-of-dose "wearing-off" symptoms. The combination optimizes levodopa delivery to the brain, helping to manage motor fluctuations and reduce the total daily dose of levodopa required.
How STALEVO 125 Works
Parkinson’s disease symptoms are associated with the depletion of dopamine in the corpus striatum. Levodopa, the metabolic precursor of dopamine, crosses the blood-brain barrier and is converted to dopamine in the brain. Carbidopa inhibits the peripheral decarboxylation of levodopa, increasing its availability for transport to the central nervous system and reducing peripheral side effects like nausea. Entacapone is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT). When administered with levodopa and carbidopa, entacapone slows the peripheral metabolism of levodopa to 3-O-methyldopa, resulting in higher and more sustained plasma levels of levodopa. This triple-mechanism approach ensures a more constant supply of levodopa to the brain, specifically addressing the "wearing-off" effect seen in advanced Parkinson's disease.
Details
- Status
- Prescription
- First Approved
- 2003-06-11
- Routes
- ORAL
- Dosage Forms
- TABLET
STALEVO 125 Approval History
What STALEVO 125 Treats
7 indicationsSTALEVO 125 is approved for 7 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinson's Disease
- Post-Encephalitic Parkinsonism
- Symptomatic Parkinsonism
- Carbon Monoxide Intoxication
- Manganese Intoxication
- Nausea
- Vomiting
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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.
STALEVO 125 FDA Label Details
ProIndications & Usage
FDA Label (PDF)Carbidopa and levodopa tablets are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidop...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.