Impax & GSK Report Positive Data from Parkinson's Drug Study
Impax aims to submit an NDA for IPX066 to FDA by the end of 2011. GSK expects to file a marketing authorization application for IPX066 in the EU during 2012.
California-based Impax Pharmaceuticals and its British partner GlaxoSmithKline have received positive data from the Phase III Ascend-PD study comparing the extended-release carbidopa-levodopa drug candidate, IPX066, with carbidopa-levodopa plus entacapone (CLE) in patients with advanced Parkinson's disease.
The trial met its primary endpoint, in terms of reducing percentage off time during waking hours. Off time, recorded by the patient, represent the functional state when medication effects have worn off and there is a return of the motor symptoms of PD.
Results from the Phase III Ascend-PD study, which was completed by 84 subjects, showed that treatment with IPX-066 reduced off time from a baseline of 5.9 hours (36.1%) to 3.8 hours (24%), whereas treatment with
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