The phase III trials investigated the efficacy and safety of oral lacosamide as adjunctive therapy in adults with uncontrolled partial seizures. The percent reduction in seizure frequency over placebo was 14.4% for the lacosamide 200 mg/day group and 15% for the lacosamide 400 mg/day group. However the figure for the 200mg group was not statistically significant. During the trial, lacosamide was generally well tolerated, with dizziness, headache and double vision being the most commonly reported adverse events.
“Lacosamide is a promising new compound with a novel mode of action, and it has the potential to play an important role in the management of epilepsy,” said Iris Loew-Friedrich, member of the Executive Board, Schwarz Pharma.
Lacosamide is an investigational compound that has already shown to be efficacious in treating both epilepsy and painful diabetic neuropathy. Unlike traditional antiepileptic drugs that affect sodium channel fast-inactivation, lacosamide is believed to selectively enhance slow-inactivation, thus reducing abnormal neuronal transmission in the brain. Additionally, lacosamide acts on a protein involved in neuronal growth (CRMP-2). The interaction of lacosamide with CRMP-2 may prevent the formation of abnormal neuronal connections in the brain. This could have a possible effect on the underlying disease.
According to Schwarz Pharma, this trial will be submitted to the regulatory agencies in both the European Union and the US as part of the marketing authorization application for lacosamide as adjunctive therapy in adults with partial seizures.