UCB announces positive results of lacosamide non-inferiority Phase III study

Belgian pharma company UCB (Euronext Brussels: UCB) has announced positive results of a Phase III non-inferiority study on lacosamide compared to carbamazepine-CR as a 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 use this as part of the submission to the European Medicines Agency of a variation file to extend the marketing authorization of lacosamide as monotherapy. This submission is planned in the first half of 2016.

This Phase III study was an international, positive controlled, multicenter, 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 adverse events were similar to those reported in previous lacosamide studies.