XenoPort says FDA extends review of restless leg syndrome drug

Nov 9 (Reuters) - XenoPort Inc (XNPT.O) has said the U.S. health regulators delayed by three months the review of its drug for restless leg syndrome, sending its shares down 4 percent.

In a statement issued on late Friday, the company and its partner GlaxoSmithKline (GSK.L) said the date has been extended to Feb. 9, 2010 for the review of drug XP13512, also known as GSK1838262.

The U.S. Food and Drug Administration had determined that a Risk Evaluation and Mitigation Strategy (REMS) was necessary for the drug.

In response to FDA's request, GSK submitted a proposed REMS and the FDA accepted this submission as a solicited major amendment to the application, the companies said.

The FDA has the option to extend the date when a major amendment not previously reviewed is submitted, the companies added.

The drug is also being studied as a treatment for post-herpetic neuralgia, or PHN, painful diabetic neuropathy, or PDN, and migraine prophylaxis.

XenoPort shares fell 5 percent in trading before the bell. They closed at $18.14 Friday on Nasdaq. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Gopakumar Warrier)