XenoPort and Glaxo says FDA review of neuropathic pain drug extended 3 months, to Feb. 2010
By APMonday, November 9, 2009
FDA extends review of XenoPort-Glaxo pain drug
NEW YORK — The Food and Drug Administration needs three more months to review an application to a neuropathic pain drug being developed by XenoPort Inc. and GlaxoSmithKline PLC, the companies said.
XenoPort and GlaxoSmithKline said late Friday the FDA should complete its review of the drug, called gabapentin enacarbil, by Feb. 9, 2010. The review period was scheduled to end Monday. The FDA wanted the companies to develop a strategy to evaluate the drug’s risks, and after GlaxoSmithKline submitted that strategy, the agency needed additional time to review it.
XenoPort is based in Santa Clara, Calif., and GlaxoSmithKline is headquartered in London. In premarket trading, XenoPort stock rose 7 cents to $18.21 from $18.14.
