XNPT congrates KEI - FDA Approves Drug For Shingles-Related Disease
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Glaxosmithkline (NYSE:GSK)
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Today : Thursday 7 June 2012
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The U.S. Food and Drug Administration has approved Horizant, a drug developed and marketed by GlaxoSmithKline PLC (GSK) and XenoPort Inc. (XNPT), for the management of postherpetic neuralgia, a nerve disease that sometimes follows shingles.
The approval follows three clinical studies involving 574 adult patients from the U.S., Canada and Germany. The recommended dosage is 600mg twice a day. The most commonly reported side effects in a 12-week study were drowsiness and dizziness.
On British drug firm Glaxo's first sale of the product after approval for the treatment of postherpetic neuralgia, Xenoport is entitled to a milestone payment of $10 million.
Roughly 100,000 people in the U.S. develop post-herpetic neuralgia after an outbreak of herpes zoster, commonly known as shingles, each year.
Horizant, which was discovered by XenoPort, was approved last year in the U.S. for the treatment of moderate-to-severe restless legs syndrome.
XenoPort is a biopharmaceutical company that develops and commercializes drugs for the potential treatment of neurological diseases.
Glaxo's American depositary shares closed at $44.38 on Wednesday and are down 2.7% so far this year. XenoPort's shares closed at $6.07 and are up 59% for the year. Both were inactive premarket.
Write to Kristin Jones at kristin.jones@dowjones.com
