UCB has announced positive results of a Phase 3 non-inferiority study designed to compare efficacy and safety of lacosamide 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.
"We are very pleased with these top-line results which reported 90% of lacosamide patients remaining seizure free for six consecutive months, demonstrating non-inferiority of lacosamide. We look forward to discussing the detailed study results with the regulatory agencies and the scientific community," said Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB. "These encouraging data support lacosamide as monotherapy for partial onset seizures, which is already approved and launched in the United States and should soon reach patients in the EU. Lacosamide is currently available in 47 countries. Our ongoing comprehensive development program includes clinical trials in primary generalized tonic-clonic seizures as well as studies in children. We aim to make the product available to many more people living with epilepsy worldwide."
"In recent years Vimpat® has provided value for patients requiring add-on therapy for their focal epilepsy," said Jeff Wren, Patient Value Head Neurology and Executive Vice President UCB. "This study suggests that it may provide similar benefits as a first-line monotherapy , building on our commitment on enhancing value for those with seizure disorders at every point in their epilepsy journey."
This Phase 3 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 observed adverse events were similar to those reported in previous lacosamide studies.
These topline results will be followed by full efficacy and safety analyses and will be submitted for presentation at an upcoming epilepsy meeting.
Lacosamide (tradename Vimpat®) is approved as adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy (ages ≥ 17 years in the U.S., ages ≥ 16 years in the EU) and in the U.S. also as monotherapy. In the EU, Lacosamide is not currently approved for use as monotherapy.