New Marketing Approval for Horizant - Drug Discovery and Development

NEW YORK (AP) – Xenoport Inc. and GlaxoSmithKline PLC said they received an additional marketing approval for their drug Horizant.

The companies said the Food and Drug Administration approved Horizant as a treatment for nerve pain that follows shingles, a viral infection related to chicken pox. Xenoport and GlaxoSmithKline said around 1 million cases of shingles, or herpes zoster, are diagnosed in the U.S. each year and about 10% of patients later develop nerve pain. The condition is called postherpetic neuralgia.

Xenoport is based in Santa Clara, Calif., and it said it will receive a $10 million payment from GlaxoSmithKline upon the first commercial sale of Horizant as a treatment for postherpetic neuralgia. The FDA approved Horizant in April 2011 as a treatment for restless legs syndrome, and it is Xenoport’s only approved drug.

Side effects of Horizant in clinical trials for postherpetic neuralgia included tiredness and dizziness.

Date: June 7, 2012
Source: Associated Press