Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Valeant Pharmaceuticals International has reported positive results for retigabine in Restore 1, the first of two Phase III pivotal trials, for this first-in-class neuronal potassium channel opener.
Subscribe to our email newsletter
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.”