Wednesday, Valeant Pharmaceuticals International (VRX) announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application, or NDA, seeking marketing approval for its investigational drug retigabine.
Retigabine is a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures.
In November, the European Medicines Agency or EMEA accepted for review the Marketing Authorization Application for retigabine.
Retigabine, in Phase 3 epilepsy trials, reduced seizure rates compared to placebo. The most common adverse reactions are dizziness, fatigue, confusional state, vertigo, tremor, abnormal coordination, diplopia, disturbance in attention, asthenia and visual blurring.
Valeant has a worldwide License and Collaboration Agreement with GlaxoSmithKline plc (GSK) to develop and commercialize retigabine. Valeant will collaborate with GSK on the development and marketing of Retigabine in the U.S., Australia, New Zealand, Canada and Puerto Rico, and GSK has an exclusive license to develop and commercialize retigabine in other countries and certain backup compounds to retigabine worldwide.
VRX is currently trading at $32.33, up $0.16 or 0.50%, on the NYSE, while GSK is trading at $42.25, down $0.20 or 0.47% on the NYSE.
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