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news.GlaxoSmithKline (GSK) and Valeant Pharmaceuticals have received European Commission's marketing authorization for their treatment for partial onset seizures, Trobalt (retigabine), with or without secondary generalisation in adults aged 18 years and above with epilepsy.
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According to GSK and Valeant, EC has given its approval on the basis of the results from pivotal Phase III studies 1 and 2 and Study 205, a Phase IIb study.
The results of the trial suggested that there was a 50% or more reduction in seizure frequency compare to placebo when a 600mg, 900mg or 1200mg dose of Retigabine was added to their current anti-epileptic drug (AED) therapy.
Valeant Research and Development head Susan Hall said there is a significant need for new AEDs and retigabine could potentially play an important role in the management of partial onset seizures in appropriate patients.