Phase III trial of Vimpat (lacosamide) as monotherapy for patients with partial-onset seizures- UCB

UCB has announced positive results of a Phase III non-inferiority study designed to compare efficacy and safety of lacosamide (Vimpat) to carbamazepine-CR (controlled release; retard tablets) as monotherapy in newly or recently diagnosed adult patients with partial-onset seizures. The study met its primary endpoint for the proportion of patients remaining seizure free for six consecutive months of treatment. UCB plans to submit to the European Medicines Agency (EMA) these data as part of its variation file to extend the marketing authorization of lacosamide as monotherapy , which is planned in the first half of 2016.

This Phase III study was an international, positive controlled, multicentre, double-blind, randomized comparison between lacosamide (200 to 600mg/day) and carbamazepine-CR (400 to 1200mg/day) used as monotherapy in 888 patients aged 16 years and older with newly or recently diagnosed epilepsy. The observed adverse events were similar to those reported in previous lacosamide studies.

Comment: Lacosamide is approved as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy (aged >17 years in the US, >16 years in the EU) and in the US also as monotherapy. In the EU, lacosamide is not currently approved for use as monotherapy. Approval of the drug as a monotherapy could significantly expand its scope in Europe, given that new patients can be initiated on the treatment and those already on an antiepileptic can be switched over to lacosamide.