Pharmaceutical Business review

GSK files Horizant sNDA with FDA

Horizant is XenoPort’s first approved product.

Horizant extended-release tablets are indicated for the management of postherpetic neuralgia (PHN) in adults patients.

GSK holds commercialization rights and certain development rights for gabapentin enacarbil in the US.

In April this year, GSK and XenoPort have received the FDA approval for Horizant extended-release tablets for the treatment of moderate-to-severe primary restless legs syndrome in adults.

The efficacy of Horizant in the treatment of patients with moderate-to-severe primary restless legs syndrome was showed in two 12-week clinical trials in adults.