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.
LIST OF FIGURES
8 Figure 1: Rytary for Parkinson’s disease – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Rytary for Parkinson’s disease
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Rytary for Parkinson’s disease
12 Figure 4: Rytary sales for Parkinson’s disease in the US, 2016–25
LIST OF TABLES
6 Table 1: Rytary drug profile
7 Table 2: Rytary pivotal trial data in Parkinson’s disease
12 Table 3: Rytary sales for Parkinson’s disease in the US ($m), 2016–25
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