Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today reported the positive results from a recently completed Phase II trial of its late-stage Parkinson’s Disease drug candidate IPX066
In this cross-over trial, IPX066 reduced subjects’ “off” time during waking hours by 2 hours compared to Sinemet (3.8 hours of “off” time for IPX066 vs. 5.8 hours for Sinemet, P<0.0001), the standard of care in Parkinson’s disease motor symptom management. “A reduction in “off” time of two hours represents a substantial improvement for Parkinson’s patients”, said Robert A. Hauser, Professor of Neurology at the University of South Florida and a study investigator. “Patients desire sustained improvement of motor symptoms, beyond that afforded by currently available oral therapies,” he added. Corresponding effects were observed in the increase of “on” time with no or non-troublesome dyskinesias. In addition, IPX066 significantly improved duration of motor function compared to Sinemet, with an effect sustained over 6 hours, as measured by walking times>
The detailed results will be presented at the XVIII WFN World Congress on Parkinson’s Disease and Related Disorders in Miami Beach, Florida, December 16 through December 19, 2009. The full abstract, entitled “Comparative Efficacy and Safety of a Novel Carbidopa-Levodopa Product (IPX066) and Sinemet® in Advanced Parkinson’s Disease” will be made available in the meeting program and the conference website (www.kenes.com/parkinson) later in the year.