FDAnews
www.fdanews.com/articles/101493-valeant-completes-enrollment-in-retigabine-trial

Valeant Completes Enrollment in Retigabine Trial

November 27, 2007

Valeant Pharmaceuticals International has achieved full enrollment in RESTORE2, its second Phase III study of retigabine in the treatment of epilepsy.

RESTORE2 is investigating retigabine at 600 and 900 mg per day, and RESTORE1, the first study, is investigating retigabine at 1,200 mg per day.

RESTORE2, which is being conducted in Europe, Israel, Australia, South Africa and the U.S., has enrolled 539 patients. RESTORE1 is being conducted in the U.S., Argentina, Mexico, Brazil and Canada.

Following the anticipated completion of the RESTORE trials in the second quarter of 2008, Valeant said it plans to file a new drug application with the FDA and a marketing authorization application in Europe.