XenoPort Says FDA Accepts New Solzira Application

NEW YORK (AP) — XenoPort Inc. said Monday that regulators agreed to review its drug candidate Solzira as a treatment for restless legs syndrome, which triggered $23 million in payments to XenoPort.

The Food and Drug Administration accepted a new drug application for Solzira for moderate to severe restless legs syndrome, a neurological condition in which people feel unpleasant or painful sensations in their legs, creating an urge to move them.

GlaxoSmithKline PLC and Astellas Pharma Inc. of Japan will make milestone payments to XenoPort through marketing partnerships. GlaxoSmithKline and XenoPort originally asked the FDA to approve Solzira for restless legs syndrome in 2008, but withdrew their application after the agency requested they reformat some clinical study data.

The companies submitted the new drug application on Jan. 9. A standard FDA review takes 10 months, which suggests the FDA would make a decision around Nov. 9.

Solzira is the lead drug candidate for Santa Clara, Calif.-based XenoPort. The company is also testing the drug against diabetic neuropathy and post-shingles pain. XenoPort does not have any products on the market.

In morning trading, XenoPort shares slipped 2 cents to $19.97. Shares of London-based GlaxoSmithKline added 68 cents, or 2.1 percent, to $29.80.