STALEVO 75
Stalevo 75 is a combination product containing levodopa, carbidopa, and entacapone indicated for the treatment of patients with Parkinson's disease. It is specifically used to replace carbidopa/levodopa and entacapone therapy, or to treat patients experiencing "wearing-off" (end-of-dose motor fluctuations) on their current levodopa/carbidopa regimen. By combining a metabolic precursor (levodopa) with two decarboxylase inhibitors (carbidopa and the COMT-inhibitor entacapone), the medication provides more sustained plasma levels of levodopa, leading to improved motor control and reduced "off" time compared to levodopa/carbidopa alone.
How STALEVO 75 Works
Parkinson’s disease symptoms result from dopamine depletion in the corpus striatum. While levodopa crosses the blood-brain barrier to be converted into dopamine, it is heavily metabolized in the periphery. Stalevo utilizes a three-pronged approach: 1. **Levodopa** serves as the metabolic precursor to dopamine. 2. **Carbidopa** inhibits aromatic amino acid decarboxylase, preventing the peripheral conversion of levodopa to dopamine. 3. **Entacapone** is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT). When carbidopa inhibits decarboxylation, COMT becomes the major metabolizing pathway for levodopa. By inhibiting COMT, entacapone further slows the clearance of levodopa from the plasma, resulting in higher and more sustained serum levels of levodopa available to enter the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2003-06-11
- Routes
- ORAL
- Dosage Forms
- TABLET
STALEVO 75 Approval History
What STALEVO 75 Treats
3 indicationsSTALEVO 75 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
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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 75 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.