GSK and Impax announce positive topline results of ASCEND-PD Phase III study of IPX066 in Advanced Parkinson’s disease
IPX066 demonstrated statistically significant improvement over carbidopa-levodopa plus entacapone in reducing the percentage of “off time” during waking hours.
- (1888PressRelease) August 16, 2011 - GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced top-line results of the ASCEND-PD Phase III clinical study of IPX066 versus carbidopa-levodopa plus entacapone (CLE), in patients with advanced Parkinson’s disease (PD). IPX066 is an extended release capsule formulation of carbidopa-levodopa (CD-LD) under investigation for the treatment of the motor symptoms of PD.
The primary endpoint of this double blind crossover study was the percentage of “off time” during waking hours as measured by patient diary. “Off time” is the functional state when patients’ medication effect has worn off and there is a return of the motor symptoms of PD. Patients entered the study with a baseline “off time” of 36.1% (5.9 hours), and at the end of the randomized IPX066 treatment phase patients had “off time” of 24.0% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for CLE (p
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