Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that it has completed enrollment of its ADVANCE-PD trial. ADVANCE-PD is a multinational Phase III trial of its late-stage product IPX066 in advanced Parkinson's disease (PD) patients with motor fluctuations. 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 second of two pivotal Phase III studies designed to support a new drug application of IPX066 in Parkinson's disease.
"We are very pleased to have completed enrollment in ADVANCE-PD, the second pivotal trial planned for submission to support our approval in Parkinson's disease," stated Michael Nestor, president of Impax Pharmaceuticals. "This achievement by our dedicated R&D team is an important milestone for IPX066 and for Impax Pharmaceuticals as we plan for potential product launch. We look forward to providing the top line results for this trial in the first half of 2011 and continue to progress toward filing the new drug application in the fourth quarter of 2011."
The ADVANCE-PD study (www.advance-pd.com) is a Phase III study of the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients with motor fluctuations. The 22-week trial is being conducted in North America and Europe, and the primary endpoint is percentage of "off" time during waking hours. The trial exceeded its enrollment objective and results are expected in the first half of 2011.
The ADVANCE-PD trial in patients with advanced PD complements the APEX-PD Study (www.apex-pd.com) being conducted in levodopa-naïve PD patients, which finished enrollment earlier this year and is ongoing. The ADVANCE-PD and APEX-PD trials follow the earlier announced successful Phase II study of IPX066 in Parkinson's patients.
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