SANTA CLARA, Calif.--(BUSINESS WIRE)--XenoPort, Inc. (Nasdaq:XNPT) announced today that Astellas Pharma Inc. plans to file a new drug application (NDA) in Japan for XP13512 (known as ASP8825 by Astellas) as a potential treatment for moderate-to-severe primary restless legs syndrome (RLS) in the second half of its 2009 fiscal year, which ends on March 31, 2010. The evidence of efficacy for the NDA filing will be based on data from Astellas’ successful Phase 2 study in RLS patients conducted in Japan and XenoPort’s clinical program conducted in the United States. Based on the outcome of a Pharmaceutical and Medical Devices Agency (PMDA) consultation meeting, Astellas has concluded that Phase 3 clinical studies in Japan will not be required for the NDA filing.
