An investigational extended release capsule formulation of carbidopa-levodopa (CD-LD)- IPX066, is aimed to treat motor symptoms of the PD.
The randomised, double-blind 2-treatment, 2-period crossover Ascend-PD study enrolled 110 subjects, of which 90 subjects enter the randomized comparative phase, following which the subjects will be enrolled in a six-month open-label extension phase.
The study results are expected in late August, 2011 while the company plans to file a New Drug Application for IPX066 in PD in the fourth quarter of 2011.
Impax earlier completed two pivotal phase III trials in advanced PD subjects and in early PD patients.
The drug is jointly developed by Impax and GlaxoSmithKline.