An extended-release capsule formulation of carbidopa and levodopa in a 1:4 ratio was approved by the Food and Drug Administration for treating Parkinson’s disease, the manufacturer announced in a statement on Jan. 8.
The combination, which will be marketed as Rytary, also is approved for postencephalitic parkinsonism and parkinsonism that may occur after carbon monoxide intoxication or manganese intoxication, according to the company, Impax Pharmaceuticals.
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The company studied the drug combination in patients with early to advanced Parkinson’s in the United States and Europe in the APEX-PD study and the ADVANCE-PD study.
The combination will be available in four strengths: 23.75 mg/95 mg (carbidopa/levodopa), 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg. The capsules, which can be swallowed whole, contain both immediate- and extended-release beads that can be sprinkled on applesauce for immediate consumption by patients who have trouble swallowing, the company said.
The company expects that the product will be available for distribution in February.
The prescribing information is available here.