Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc has completed enrolment of its APEX-PD trial. APEX-PD is a multinational phase-III trial of its late-stage drug candidate IPX066 in subjects with early Parkinson's disease (PD). IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management. This is the first of two phase-III studies designed to support marketing approval of IPX066 in Parkinson's disease.

"We are very pleased to have completed enrollment in APEX-PD, meeting an important milestone for IPX066 and for Impax Pharmaceuticals as we plan for potential product launch," said Michael Nestor, president of Impax Pharmaceuticals. "We look forward to revealing the top line results for this trial in early 2011. We continue to plan to file the new drug application in the fourth quarter of 2011."

The APEX-PD study is a phase-III randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of IPX066 in subjects with early Parkinson's disease. The study is evaluating three doses of IPX066 versus placebo in subjects with mild symptoms of PD. The trial has met its enrolment goal of 350 subjects who were randomized into one of four treatment groups.

IPX066 is an investigational extended release carbidopa-levodopa product intended to produce a fast and sustained concentration of levodopa, potentially improving PD clinical symptom management.

Impax Labs is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.