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Impax Pharmaceuticals launches treatment for Parkinson's disease


HAYWARD, Calif. — Impax Pharmaceuticals on Thursday announced that the U.S. Food and Drug Administration approved Rytary, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication. Rytary is not for use in patients using nonselective monoamine oxidase inhibitors. 


"The FDA approval of Rytary is an important new development for the treatment of Parkinson's disease and provides an extended-release carbidopa-levodopa product that treats Parkinson's disease," stated Fred Wilkinson, president and CEO of Impax Laboratories. "Rytary is designed to address one of the most significant unmet needs for patients living with Parkinson's disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled," he said. "Today's approval of RYTARY is also a significant milestone for Impax because it is our first branded drug internally developed and approved for commercialization."


Rytary contains immediate-release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio, and provides both initial and extended levodopa plasma concentrations after a single dose. Rytary may be swallowed whole or, for patients who have trouble swallowing, the capsule may be opened and the beads sprinkled on applesauce and consumed immediately.


Impax expects the four strengths of Rytary, 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg (carbidopa/levodopa) to be available for commercial distribution in February 2015.


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