Istradefylline: Phase III data

A double-blind, Japanese Phase III trial in 373 PD patients with motor complications who were receiving levodopa showed that once-daily 20 and 40 mg KW-6002 each met the primary endpoint of significantly reducing daily "off" time in which patients experienced symptoms of their PD from baseline to week 12 vs. placebo (0.99 and 0.96 hours, respectively, vs. 0.23 hours; p=0.003 for both). Both doses of KW-6002 were well tolerated. Kyowa said it plans to submit an NDA in Japan for KW-6002 to treat PD, but would not disclose a timeframe. In 2006, the company reported data from 3 Phase III trials of KW-6002 for the indication showing that the compound met the same primary endpoint in 1 of the trials, but missed the endpoint in the other 2 (see BioCentury, March 13, 2006). ...