Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GlaxoSmithKline (GSK) has filed a supplemental new drug application (sNDA) seeking approval for Horizant (gabapentin enacarbil) extended release tablet with the US Food and Drug Administration (FDA).
Subscribe to our email newsletter
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.