Retigabine effective in Ph III epilepsy trial

California, USA-based specialty drug developer Valeant Pharmaceuticals says that data from a Phase III trial of its neuronal potassium channel opener retigabine confirm the drug's efficacy as a treatment for epilepsy patients suffering from partial-onset seizures.

The RESTORE trial, the first of two pivotal Phase III assessments, was a placebo-controlled examination of the drug's safety and efficacy in adult epileptics who continue to experience seizures despite prior treatment. Participants were randomized to receive either a 1,200mg daily dose of retigabine administered in one of three different regimens, or placebo.

The results showed that retigabine provides a statistically-significant reduction in the frequency of partial onset seizures compared with placebo (44.3% versus 17.5%), including as a maintenance treatment (54.5% vs 18.9%). Valeant said that the drug had met both Food and Drug Administration and European Medicines Authority (EMEA) guidance, and added that it plans to file a New Drug Application and a Marketing Authorization Application with the respective bodies before the end of 2008.