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.