Market Overview

XenoPort Reports Feedback from FDA on XP23829

XenoPort (NASDAQ: XNPT) today reported an update on XP23289 development,
including feedback from the U.S. Food and Drug Administration (FDA) on
the potential development plans, and XenoPort's progress on
commercializing HORIZANT® (gabapentin enacarbil)
Extended-Release Tablets.

XenoPort reported today that it received feedback from the FDA Division
of Neurology Products regarding potential development plans for XP23829
as a potential treatment for patients with relapsing forms of multiple
sclerosis (MS). Based on the feedback, XenoPort believes that the FDA
would allow XenoPort to initiate potential Phase 3 clinical development
using XP23829 doses that produce monomethyl fumarate (MMF) exposure
similar to that produced by the approved dose of TECFIDERA (dimethyl
fumarate).

See full press release

Posted-In: News Guidance Contracts FDA Management Global

 

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