GlaxoSmithKline, XenoPort Get FDA Approval For Horizant

LONDON-- Pharmaceutical and healthcare company GlaxoSmithKline PLC (GSK.LN) Thursday said the United States Food and Drug Administration, or FDA, has approved Horizant (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults.

MAIN FACTS:

-Horizant was discovered and is being developed by XenoPort Inc. (XNPT).

-Efficacy and safety of Horizant for the management of PHN was evaluated in a single 12-week principal efficacy trial, plus two supportive studies that all met their respective primary endpoints.

-Three clinical studies involved 574 adult patients from the U.S., Canada and Germany.

-Recommended dosage for the management of PHN in adults is 600 mg, or milligram, twice daily.

-XenoPort is entitled to a milestone payment of $10 million from GlaxoSmithKline following the first commercial sale of the product after approval for PHN.

-Shares of GlaxoSmithKline at 1037 GMT up 13 pence, or 1%, at 1439.5 pence.

-Write to Tapan Panchal at tapan.panchal@dowjones.com