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news.GlaxoSmithKline and XenoPort, a biopharmaceutical company, have withdrawn the the new drug application for Solzira extended release tablets for the treatment of moderate-to-severe primary restless legs syndrome.
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The FDA has requested that the data in a single study be reformatted. In addition, GlaxoSmithKline (GSK) will conduct a review of other trial data sets taking this input into account. The withdrawal does not relate to the content of the filing. GSK plans to resubmit the new drug application (NDA) quickly once this work is complete.
The resubmission will lead to a delay in the receipt by XenoPort of milestone payments of $23 million in the aggregate from GSK and Astellas Pharma, which are associated with the acceptance by the FDA of the NDA for Solzira.
Solzira is said to be a new chemical entity that is designed to improve upon the pharmacokinetics of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.