Drug Overview
Rytary (Impax Laboratories) is a novel oral capsule formulation of carbidopa and levodopa that contains both an immediate-release and a sustained-release levodopa component. Rytary is dosed three times daily, although its pharmacokinetic profile allows for smoother levodopa levels and consequently fewer motor fluctuations than conventional, immediate-release carbidopa + levodopa.
Rytary was finally approved by the US Food and Drug Administration in January 2015, despite over three years of regulatory scrutiny. Impax’s first submission in December 2011 resulted in a complete response letter requiring a re-inspection of its manufacturing facility. In the meantime, Impax’s former development partner GlaxoSmithKline terminated their agreement, leaving Impax to conclude the regulatory process and commercialize the product by itself.
Rytary (Impax Laboratories) is a novel oral capsule formulation of carbidopa and levodopa that contains both an immediate-release and a sustained-release levodopa component. Rytary is dosed three times daily, although its pharmacokinetic profile allows for smoother levodopa levels and consequently fewer motor fluctuations than conventional, immediate-release carbidopa + levodopa.
Rytary was finally approved by the US Food and Drug Administration in January 2015, despite over three years of regulatory scrutiny. Impax’s first submission in December 2011 resulted in a complete response letter requiring a re-inspection of its manufacturing facility. In the meantime, Impax’s former development partner GlaxoSmithKline terminated their agreement, leaving Impax to conclude the regulatory process and commercialize the product by itself.
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