FDA Approves Extended Release Levodopa-Carbidopa


Today MJFF-awardee Impax Pharmaceuticals announced that the U.S. Food and Drug Administration approved RYTARY, an extended-release oral capsule formulation of levodopa-carbidopa, for the treatment of Parkinson’s disease.

“The FDA approval of RYTARY (pronounced rye-TAR-ee) is an important new development for the treatment of Parkinson’s disease,” said Fred Wilkinson, president and CEO, 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.”

Participants in a Phase III clinical trial experienced nearly an hour and a half less “off time” per day when taking the drug, as compared with carbidopa-levodopa plus entacapone, another drug to lengthen efficacy of levodopa.

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