April 7, 2011 / 1:47 AM / 9 years ago

UPDATE 1-FDA approves drug for restless legs syndrome

* FDA approves GlaxoSmithkline’s, XenoPort’s Horizant

NEW YORK, April 6 (Reuters) - GlaxoSmithKline Plc (GSK.L) and XenoPort Inc XNPT.O have received approval from the U.S. Food and Drug Administration for Horizant, a drug to treat restless legs syndrome, the companies said on Wednesday.

Horizant is the first drug in its class that the FDA has approved to treat moderate-to-severe primary restless legs syndrome, the companies said.

GlaxoSmithKline and XenoPort said the FDA approval came after two 12-week clinical trials in adults.

The FDA last year sought additional information from the companies on Horizant, after declining to approve it because of a potential link to cancer found in rats. (Reporting by Maria Aspan; editing by Carol Bishopric)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below