Lacosamide (Vimpat®) is a functionalized
amino acid (available orally and intravenously) approved in the EU and the USA for use as monotherapy and adjunctive
therapy for the treatment of focal-onset
seizures in adults, adolescents and children aged ≥ 4 years with
epilepsy. In adults and adolescents (aged ≥ 16 years), oral
lacosamide as adjunctive
therapy to other
antiepileptic drugs was generally effective in reducing seizure frequency during short-term (up to 18 weeks) treatment, with efficacy sustained over the longer-term (up to 8 years). Moreover, patients were effectively switched from adjunctive oral
lacosamide to the same dosage of intravenous
lacosamide. Oral
lacosamide was an effective conversion to monotherapy agent in this patient population and as monotherapy demonstrated noninferiority to
carbamazepine controlled release in terms of seizure freedom.
Antiepileptic benefits were maintained during longer-term (≤ 2 years) monotherapy. The
antiepileptic efficacy of
lacosamide in children aged ≥ 4 years has been extrapolated from data from adults and adolescents, with a similar response expected provided paediatric dosage adaptations are used and safety is demonstrated. Indeed, preliminary data demonstrated the efficacy of short-term (16 weeks) adjunctive
lacosamide in patients aged ≥ 4 to < 17 years. Oral
lacosamide was generally well tolerated over the short- and longer-term when administered as adjunctive
therapy, a conversion to monotherapy agent and monotherapy in adults and adolescents and when administered as adjunctive
therapy in children aged ≥ 4 years. Thus,
lacosamide is a useful option for the management of focal-onset
seizures across a broad age range, starting as early as 4 years of age.