Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that IPX066 APEX-PD Phase III clinical study data will be presented in a Late Breaker Session at the 63rd annual meeting of the American Academy of Neurology Conference in Honolulu, Hawaii, held from April 9 to April 16. IPX066 is an investigational extended release carbidopa-levodopa (CD-LD) product intended to treat the motor symptoms of Parkinson's disease.
On November 18, 2010, the Company reported positive top-line results of the APEX-PD trial. The results demonstrated the safety and efficacy of IPX066 in patients with early PD. The study met its primary efficacy endpoint of change from baseline in the sum of United Parkinson's Disease Rating Scale (UPDRS) Parts II and III score at end of study. The study also met several secondary endpoints including, Clinician Global Impression of change and Patient Global Impression of change. There were no unexpected drug-related serious adverse events observed in IPX066 treated subjects.
The Late-Breaker oral presentation of IPX066 APEX-PD results is as follows:
Date and Time:
April 13, 2011 at 5:00 PM (local time)
Presentation Title and Number:
Double-Blind, Placebo-Controlled Fixed-Dose Trial of IPX066, a Novel Carbidopa-Levodopa (CD-LD) Extended-Release Formulation, in Early Parkinson's Disease (APEX-PD Trial); LBS.001
Rajesh Pahwa, MD, Professor of Neurology, University of Kansas Medical Center