STALEVO 150
Stalevo 150 is a combination product containing levodopa (150 mg), carbidopa (37.5 mg), and entacapone (200 mg). It is indicated for the treatment of patients with idiopathic Parkinson's disease to replace immediate-release carbidopa/levodopa and entacapone, or to substitute for carbidopa/levodopa therapy in patients experiencing end-of-dose "wearing-off" symptoms. By combining a dopamine precursor (levodopa) with two distinct enzyme inhibitors (carbidopa and entacapone), the medication optimizes the delivery of levodopa to the brain, extending its half-life and providing more stable symptomatic relief.
How STALEVO 150 Works
Parkinson's disease symptoms result from dopamine depletion in the corpus striatum. Levodopa, the metabolic precursor of dopamine, crosses the blood-brain barrier to replenish these levels. However, levodopa is extensively metabolized in the periphery. Carbidopa inhibits aromatic amino acid decarboxylase (AAAD), preventing the peripheral conversion of levodopa to dopamine. Entacapone is a selective, reversible inhibitor of catechol-O-methyltransferase (COMT). When AAAD is blocked by carbidopa, COMT becomes the major metabolizing pathway for levodopa. By inhibiting both AAAD and COMT, Stalevo significantly increases the area under the curve (AUC) and the elimination half-life of levodopa, ensuring more sustained dopaminergic stimulation in the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2003-06-11
- Routes
- ORAL
- Dosage Forms
- TABLET
STALEVO 150 Approval History
What STALEVO 150 Treats
5 indicationsSTALEVO 150 is approved for 5 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
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Active Pipeline
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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 150 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.