The US Food and Drug Administration (FDA) has accepted a New Drug Application from Valeant Pharmaceuticals to review the investigational epilepsy treatment retigabine.
The company is seeking marketing approval for retigabine, which is a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures.
The drug has also been accepted for review by the European Medicines Agency, after the Marketing Authorisation Application was confirmed on 17 November 2009.
The request for approval is based on Phase III epilepsy trials, which showed retigabine reduced seizure rates compared to patients taking placebo.
Valeant has an agreement to commercialise retigabine with GlaxoSmithKline (GSK), and will collaborate with GSK on the development and marketing of retigabine in the US, Australia, New Zealand, Canada and Puerto Rico.
GSK has an exclusive license to develop and commercialise retigabine in countries outside of the collaboration territory and certain backup compounds to retigabine worldwide.