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Monday, 12/05/2011 9:20:18 AM

Monday, December 05, 2011 9:20:18 AM

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Xenoport announces XP21279 Phase 2 clinical trial results in patients with advanced Parkinson's Disease - improvement with 279/CD was not statistically better than the improvement seen with optimized Sinemet (XNPT) 4.83 : Co announced today preliminary top-line results of a Phase 2, randomized, crossover clinical trial that compared optimized treatment with either Sinemet or XP21279 co-formulated with carbidopa in advanced Parkinson's disease patients with motor fluctuations. 279/CD dosed three times per day reduced mean daily "off time" by 46% compared to baseline when the patients were taking their pre-trial Sinemet dosing regimen. However, in the primary analysis of the trial, the improvement with 279/CD was not statistically better than the improvement seen with optimized Sinemet dosed four or five times per day during the double-blind phase of the trial. All treatment-emergent adverse events were mild to moderate in severity. During the double-blind phase of the trial, dyskinesias were the most common adverse event. The incidence of new or worsening dyskinesias during the double-blind phase of the trial was 11% for Sinemet and 13% for 279/CD. There were no serious adverse events.
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