Phase III success for Vimpat (UCB) as monotherapy for treatment of partial onset seizures
Positive results are announced of a Phase III study designed to evaluate the efficacy and safety of conversion to Vimpat (lacosamide)from UCB as monotherapy in adult patients with partial-onset seizures with or without secondary generalization compared with a historical control.
The study met its primary endpoint demonstrating that the exit rate for patients on lacosamide (400 mg/day) was significantly lower than the historical control. UCB plans to submit these data as part of its supplemental New Drug Application for lacosamide to the FDA, which is planned in the second half of 2013. These data support the development program for lacosamide as monotherapy for partial onset seizures, starting in the United States. Lacosamide is currently approved in 36 countries as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.