Retigabine demonstrated statistically significant results on the primary efficacy endpoints important for regulatory review by both the FDA and the European Medicines Evaluation Agency (EMEA). Restore 1 evaluated the 1200mg daily dose of retigabine (the highest dose in the Restore program) versus placebo in patients taking stable doses of 1 – 3 additional anti-epileptic drugs (AEDs). Retigabine is being developed as an adjunctive treatment for adult epilepsy patients with refractory partial-onset seizures.
Michael Pearson, chairman and CEO of Valeant, said: “Results from Restore 2, our second pivotal Phase III clinical trial studying lower doses of retigabine, are expected during the second quarter. We anticipate filing a new drug application for retigabine with the FDA and a marketing authorization application to the EMEA before the end of 2008.”