Content about Xenoport

August 11, 2011

Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.

LONDON — Drug makers GlaxoSmithKline and XenoPort are seeking expanded approval for their restless legs syndrome treatment.

The drug makers this week announced the submission of a supplemental new drug application to the Food and Drug Administration, requesting approval for Horizant (gabapentin enacarbil) extended-release tablets as a treatment for postherpetic neuralgia, a nerve pain that commonly is seen in patients with shingles. GSK submitted the sNDA on behalf of the two companies.

April 7, 2011

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

The FDA approved Horizant (gabapentin enacarbil) as a once-daily treatment for moderate-to-severe RLS.

“People with restless legs syndrome can experience considerable distress from their symptoms,” FDA Division of Neurology Products director Russell Katz said. “Horizant provides significant help in treating these symptoms.”