GlaxoSmithKline (GSK) and XenoPort, Inc announced that GSK has resubmitted the New Drug Application (NDA) to the US 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.

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.

XenoPort is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilise the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs.