GSK and XenoPort resubmit NDA for Solzira in restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

The FDA had requested that the data in a single study be reformatted. In addition, GSK conducted a review of other clinical studies taking this input into account. The withdrawal was not related to the content of the filing.

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Solzira - is 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.