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GSK, XenoPort Will Resubmit Solzira NDA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline and XenoPort, Inc. withdrew the NDA for Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The FDA has requested that the data in a single study be reformatted. GSK will conduct a review of other trial data sets as well. The withdrawal does not relate to the content of the filing. GSK plans to resubmit the NDA as soon as the revisions are made.
   
The resubmission delays a $23 million milestone payment to XenoPort from GSK and Astellas Pharma, associated with the acceptance of the NDA for Solzira. Solzira is a new chemical entity that is designed to improve upon the pharmacokinetics of gabapentin by using high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.

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