Impax Pharmaceuticals has completed patient enrolment in a Phase III comparitive study of IPX066 versus immediate-release carbidopa-levodopa and entacapone in subjects with advanced Parkinson’s disease.
IPX066, an investigational extended-release capsule formulation of carbidopa-levodopa, has been developed in collaboration with GlaxoSmithKline.
The randomised, double-blind, two-treatment, two-period crossover study enrolled 110 people, 90 of whom were entered into the comparative phase of the study, following which they will be enrolled in a six-month open-label extension phase.
In the study, the primary efficacy parameter is the per cent “off time” during waking hours based on the patients’ Parkinson’s disease diaries.
The Phase III study results are expected in late August 2011.
The company said that it plans to file a new drug application for IPX066 in the fourth quarter of 2011.