Journal Publishes Data on Valeant's Epilepsy Treatment

Valeant Pharmaceuticals has announced the publication in Neurology of Phase II data on retigabine, a first-in-class neuronal potassium channel opener being developed as an adjunctive treatment for partial-onset seizures in patients with refractory epilepsy.

The study authors concluded that retigabine was efficacious with a demonstrated reduction in monthly seizure rates in this study. Two pivotal Phase III trials, RESTORE1 and RESTORE2, are currently under way to further investigate the efficacy and safety of the drug, Valeant said.

"There is a clear need for the development of antiepileptic drugs with new mechanisms of action to improve the management of patients whose epilepsy is not controlled by current medications," lead study author Roger Porter said. "This new molecule clearly acts by way of a different neuronal mechanism and, if approved, would meet a market need."

In the study, investigators found that during the eight-week dose-escalation and maintenance periods, the addition of retigabine 600, 900 or 1,200 mg per day significantly reduced median monthly seizure frequency compared with baseline by 23, 29 and 35 percent, respectively. The reductions in the 900- and 1,200-mg groups were significantly greater than in the placebo group. Additionally, the percent of responders -- those who had a 50 percent or greater reduction in seizure frequency -- was significantly greater for the 900- and 1,200-mg groups than placebo.

The double-blind study was conducted at 73 centers in 19 countries and included 396 patients. Dosing of retigabine was increased gradually over a period of eight weeks and was then maintained for an additional eight weeks.