Stalevo (Novartis/Orion), indicated for the treatment of Parkinson’s disease patients with end-of-dose wearing-off symptoms, contains a combination of the catechol-O-methyltransferase (COMT) inhibitor entacapone, levodopa, and an AADC inhibitor (carbidopa). Stalevo is used for patients already stabilized on carbidopa + levodopa and Comtan (entacapone; Novartis/Orion) separately. COMT inhibitors increase the efficacy and bioavailability of levodopa, while entacapone is a selective and reversible COMT inhibitor that prevents the conversion of levodopa to 3-O-methyldopa and other non-beneficial metabolites.
Stalevo was first approved in the US in June 2003, in the EU in October 2003, and in Japan in July 2014. Orion has exclusive marketing rights for the product in certain EU countries, while Novartis markets the drug elsewhere, although Stalevo now faces widespread competition from generic equivalents.
LIST OF FIGURES
9 Figure 1: Stalevo for Parkinson’s disease – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Stalevo for Parkinson’s disease
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Stalevo for Parkinson’s disease
13 Figure 4: Stalevo sales for Parkinson’s disease across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Stalevo drug profile
7 Table 2: Stalevo pivotal trial data in Parkinson’s disease
14 Table 3: Stalevo sales for Parkinson’s disease across the US, Japan, and five major EU markets, by country ($m), 2016–25
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