STALEVO 50
Stalevo 50 is a combination of levodopa (50 mg), carbidopa (12.5 mg), and entacapone (200 mg) indicated for the treatment of patients with Parkinson's disease. It is used to replace carbidopa/levodopa and entacapone therapy, or as an alternative for patients experiencing end-of-dose "wearing-off" motor fluctuations. The inclusion of carbidopa and entacapone increases the bioavailability and half-life of levodopa, allowing for more sustained dopamine levels in the brain and reducing the "off" time associated with standard levodopa therapy.
How STALEVO 50 Works
Parkinson’s disease symptoms are linked to the depletion of dopamine in the corpus striatum. Levodopa, the metabolic precursor of dopamine, crosses the blood-brain barrier and is converted into dopamine to relieve motor symptoms. Carbidopa and entacapone are used to optimize levodopa delivery. Carbidopa inhibits the peripheral decarboxylation of levodopa by aromatic amino acid decarboxylase. Entacapone is a
Details
- Status
- Prescription
- First Approved
- 2003-06-11
- Routes
- ORAL
- Dosage Forms
- TABLET
STALEVO 50 Approval History
What STALEVO 50 Treats
3 indicationsSTALEVO 50 is approved for 3 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
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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.
STALEVO 50 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.