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XenoPort Submits Investigational New Drug Application for XP23829 as a Potential Treatment of RRMS
XenoPort, 05/25/2012
XenoPort, Inc. announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to begin clinical studies of XP23829 as a potential treatment for relapsing–remitting multiple sclerosis (RRMS). Following clearance of the IND by the FDA, the first Phase 1 clinical trial to be conducted in healthy subjects will commence. This study is intended to examine the safety, tolerability and pharmacokinetics of XP23829, including confirmation of its conversion to monomethyl fumarate (MMF), and the performance of four novel formulations of XP23829 designed to have different drug release mechanisms and/or time profiles.