Content about RLS

December 16, 2011

A drug made by Pfizer shows "significant" benefit to patients with restless legs syndrome, according to results of a late-stage clinical trial announced Friday.

NEW YORK — A drug made by Pfizer shows "significant" benefit to patients with restless legs syndrome, according to results of a late-stage clinical trial announced Friday.

The drug maker said Lyrica (pregabalin) produced statistically significant improvements in patients with RLS compared with placebo and pramipexole after 12 weeks of treatment. In the phase-3 study, A0081186, 300 mg of Lyrica, 0.25 mg of pramipexole, 0.5 mg of pramipexole or placebo was given to patients on a daily basis.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

HAYWARD, Calif. — The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

Impax Pharmaceuticals, as the division is known, said it filed an investigational new drug application with the Food and Drug Administration for IPX159 and started a phase-1 study.

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.”