GSK, XenoPort win FDA approval for Horizant extended-release tablets

Horizant is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults.

It is not recommended for patients who are required to sleep during the daytime and remain awake at night.

Horizant, also referred to as GSK1838262/XP13512, is a patented new chemical entity discovered and developed by XenoPort.

It uses the body’s nutrient transport mechanisms that are believed to facilitate its absorption into the body.

XenoPort CEO Ronald Barrett said this significant milestone represents the culmination of the company’s efforts to develop a non-dopaminergic therapy for patients with Restless Legs Syndrome.

"We hope that we can continue to develop other important medicines that can provide meaningful treatment benefit to sufferers of central nervous system disorders," Barrett said.