FDA Approves Lacosamide for Pediatric Partial-Onset Seizures
The FDA granted approval based on the extrapolation of efficacy data from adults to children.
The Food and Drug Administration (FDA) has approved Vimpat (lacosamide; UCB) for the treatment of partial-onset seizures in pediatric patients ≥4 years old. As the safety of Vimpat injection has not been established in pediatric patients, this approval is only for the oral solution or tablet formulations.
The FDA granted approval based on the extrapolation of efficacy data from adults to children; safety and pharmacokinetics data was also collected in children. The safety and efficacy of Vimpat as monotherapy and adjunctive therapy for the treatment of partial-onset seizures in adults has been previously established in 4 multicenter, randomized, controlled clinical trials.
While the exact mechanism of action is unknown, in vitro electrophysological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.
Vimpat is a Schedule V controlled substance. It is available in 3 formulations: tablet, oral solution, and injection.
UCB's VIMPAT® (lacosamide) now approved by FDA to treat partial-onset seizures in pediatric epilepsy patients [press release]. Atlanta, GA: UCB. Published November 6, 2017. Accessed November 14, 2017.