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news.Impax Pharmaceuticals and GlaxoSmithKline (GSK) have released top-line results from a double-blind, randomized, 2-week crossover Ascend-PD Phase III trial evaluating IPX066 versus carbidopa-levodopa plus entacapone (CLE) in patients with advanced Parkinson's disease (PD).
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The primary endpoint of the trial was the percentage of ‘off time’ during waking hours as measured by patient diary.
‘Off time’ is the functional state when patients’ medication effect has worn off and there is a return of the motor symptoms of PD.
The study results demonstrated 33.5% decrease in percent ‘off time’ for IPX066 from baseline vs. a 10% decrease for CLE.
The study showed 84 minute improvement in ‘off time’ over CLE therapy with a corresponding increase in ‘on time’ without troublesome dyskinesia.
The data from the trial will be used for the submission of new drug application (NDA) for IPX066 to the US Food and Drug Administration (FDA).
Further, GSK intends to file marketing authorization application for IPX066 in the European Union in 2012.
Earlier in December 2010, Impax Pharma and GSK have partnered for the development and commercialization of IPX066 .
Impax Pharma chief scientific officer Suneel Gupta said consistent with their earlier Advance-PD Phase III study findings, this study also demonstrates that IPX066 provides efficacy across a range of clinically meaningful measures in advanced PD.