GlaxoSmithKline and XenoPort have withdrawn their NDA for Solzira, a treatment for moderate-to-severe primary Restless Legs Syndrome. The FDA wants data in a single study to be reformatted, and GSK will conduct a review of other trial data sets taking this input into account. The companies stressed that the withdraw isn't in relation to the content of the filing, and that Solzira would be re-filed as soon as the adjustments are made. The withdraw delays GSK and Astellas Pharma's $23 million milestone payment to XenoPort.
- see the release for more