GlaxoSmithKline, Xenoport Submit New Application For Solzira

Edited Press Release

LONDON (Dow Jones)

GlaxoSmithKline and XenoPort said Friday 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, it said.

The withdrawal was not related to the content of the filing, GSK said.

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