FDA approves GSK restless legs drug

Requip (ropinirole HCl) is a second-generation dopamine agonist that directly stimulates dopamine receptors in the brain. Although its exact cause is unknown, researchers believe that the underlying cause of restless legs syndrome (RLS) may be related to dopamine, a chemical that carries the signals between nerve cells that control body movement.

The approval is supported by data from four double-blind, randomized, placebo- controlled clinical trials in adults diagnosed with RLS. In the most recently completed US trial, Requip significantly improved symptoms of moderate-to-severe primary RLS in patients from baseline to week 12.

Long-term maintenance of efficacy in the treatment of RLS was demonstrated in a 36-week relapse prevention study. In this trial, patients taking Requip demonstrated a significantly lower relapse rate compared with patients randomized to placebo.

“Requip targets what doctors believe may be an underlying cause of the disorder, which is dysfunction of a system involving the brain chemical dopamine,” said Dr William Ondo, associate professor of neurology at Baylor College of Medicine, Texas. “Now there is an approved treatment specifically for moderate-to-severe primary RLS which should help to validate this under-recognized and misunderstood condition.”