IPX066 Demonstrates Efficacy and Safety in ADVANCE-PD Phase III Study in Treatment of Advanced Parkinson’s Disease
March 14 2011 - 4:01PM
Business Wire
Impax Pharmaceuticals, the branded products division of Impax
Laboratories, Inc. (NASDAQ: IPXL), today announced statistically
significant, positive, top-line results of the ADVANCE-Parkinson’s
Disease (PD) Phase III clinical study of the safety and efficacy of
IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in
advanced PD patients experiencing motor fluctuations. IPX066 is an
investigational extended release (ER) CD-LD product. The ADVANCE-PD
results demonstrated that IPX066 produced significantly improved
control of motor symptoms as compared to IR CD-LD in multiple
clinical measures in subjects with advanced PD.
The primary endpoint of this comparison study of IPX066 to IR
CD-LD was the percentage of “off time” during waking hours. IPX066
demonstrated a 37% improvement from baseline for IPX066 vs. a 17%
improvement from baseline for IR CD-LD (p
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