Wednesday July 5, 2006 17:30–19:00 Hall 1 Schwarz Pharma & Valeant Pharmaceuticals International Satellite Symposium What's around the corner: AEDs in late development

Abstract

1 E. Ben‐Menachem ( 1 Neurologkliniken, Sahlgrenska Universitetssjukhuset, Goteberg, Sweden )Lacosamide is in Phase 3 of clinical development for the adjunctive treatment of epilepsy and neuropathic pain. Currently the mode of action (MOA) is under investigation since it has been previously demonstrated that lacosamide does not share a MOA with other currently marketed antiepileptic drugs (AEDs). The drug can be administered orally or intravenously. Results from pharmacokinetic studies suggest that lacosamide has a low potential for drug‐drug interactions, and it appears that lacosamide has a minimal risk for affecting the pharmacokinetics of commonly prescribed concomitant AEDs for the treatment of epilepsy.In a double‐blind, randomized, placebo‐controlled, multicenter trial for the treatment of partial seizures (SP667), lacosamide was administered orally in doses of 200 mg, 400 mg and 600 mg divided in 2 daily doses. In this trial, lacosamide demonstrated a statistically significant reduction in seizure frequency over placebo. Moreover, the 50% responder rate (defined as patients with at least a 50% reduction in seizure frequency) was statistically significant.A further trial (SP616) investigated the safety, tolerability and pharmacokinetics of IV lacosamide as replacement for oral lacosamide in patients with partial‐onset seizures. The nature of AEs reported following 60‐ and 30 minute infusions of lacosamide was consistent with AEs reported following oral administration of lacosamide.Dose‐related adverse events include dizziness, nausea, fatigue, ataxia, vision abnormal, diplopia, and nystagmus.The currently available results justify the further development of lacosamide for the treatment of epilepsy.