Lacosamide的临床研究.pdfVIP

Neurotherapeutics: The Journal of the American Society for Experimental NeuroTherapeutics Lacosamide Pamela Doty,* G. David Rudd,* Thomas Stoehr,† and Dirk Thomas† *SCHWARZ BIOSCIENCES, Inc., Research Triangle Park, North Carolina 27709; and †SCHWARZ PHARMA AG, Monheim, Germany Summary: Lacosamide is a new chemical entity being inves- pared with placebo. In addition, 50% responder rates for tigated as an adjunctive treatment for epilepsy, as well as lacosamide (400 and 600 mg/day) were statistically superior to monotherapy for diabetic neuropathic pain. Lacosamide ap- placebo. The most frequently reported adverse events (10% pears to have a dual mode of action: selective enhancement of of lacosamide-treated patients) included dizziness, headache, sodium channel inactivation and modulation of collapsin re- and nausea. A double-blind, double-dummy randomized trial of sponse mediator protein-2. Rapidly and completely absorbed intravenous lacosamide (30- and 60-minute infusion) as re- after oral administration, lacosamide has an elimination half- placement for oral lacosamide showed that the safety and tol- life of approximately 13 hours and a low potential for drug erability profiles were comparable for intravenous and oral interactions. Additionally, lacosamide exhibits linear, dose- lacosamide. The efficacy and safety results from completed proportional pharmacokinetics with low intra- and interpatient clinical trials, as well as the favorable pharmacokinetic profile, variability. Randomized controlled trials of adjunctive lacos- suggest that lacosamide may represent a significant advance in amide (200, 400, and 600 mg/day)