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news.Sweden-based specialty pharmaceutical company Meda has reported positive results from Phase III epilepsy study. Study results demonstrated that Retigabine as an adjunctive treatment resulted in statistically significant reduction of seizures and that the response dose-dependent.
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According to the company, Retigabine comprises a new way of affecting potassium channels in the central nervous system. It has been documented to treat epilepsy and has a different mechanism of action compared to current antiepileptic therapies.
The study, Restore 2 is a randomized, double-blind, placebo-controlled Phase III study (600mg and 900mg) with the aim to compare Retigabine versus placebo in patients on antiepileptic drug therapy.
According to GlaxoSmithKline and Valeant, the registration application for the first indication, epilepsy, is expected to be submitted early 2009 in both the US and in Europe.