Impax Pharmaceuticals Completes Enrollment In APEX-PD Phase III Trial Of IPX066 In Parkinson's Disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that it has completed enrollment 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 enrollment goal of 350 subjects who were randomized into one of four treatment groups.


About IPX066 and Parkinson's Disease (PD)


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. IPX066 has the potential to offer improved and more reliable control of PD symptoms, leading to clinically meaningful reductions in "off" time, a key objective in the management of PD. "Off-time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson symptoms. In addition, IPX066 extended release formulation is designed to reduce dosing frequency, enhancing patient convenience.


Parkinson's disease is a chronic neurodegenerative movement disorder affecting an estimated one million people in the U.S. About $1 billion per year is spent on medications to treat PD in the U.S.


Source

Impax Laboratories, Inc.

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