Rytary
Author: Daniel Chancellor
Publisher: Datamonitor Healthcare
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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.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Rytary : Parkinson’s disease
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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