Journal
PHARMACEUTICAL SCIENCE TO IMPROVE THE HUMAN CONDITION: WINNERS AND FINALISTS FOR THE PRIX GALIEN USA AWARDS 2013
Volume 1329, Issue -, Pages 18-32Publisher
BLACKWELL SCIENCE PUBL
DOI: 10.1111/nyas.12513
Keywords
lacosamide; pharmacokinetics; drug-drug interactions; focal epilepsy
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Lacosamide (LCM) is a functionalized amino acid specifically developed for use as an antiepileptic drug (AED) and is currently indicated as adjunctive treatment for partial-onset seizures inadults with focal epilepsy (maximum approved dose 400 mg/day). Characterization of the pharmacokinetic profile is an important aspect in the development of LCM. Studies in healthy subjects and in patients with focal epilepsy have established that LCM has several favorable pharmacokinetic characteristics, including rapid absorption and high oral bioavailability not affected by food, linear and dose-proportional pharmacokinetics, lowinter-and intraindividual variability, lowplasma protein binding, renal elimination, and a low potential for clinically relevant pharmacokinetic drug-drug interactions both with AEDs and other common medications. Studies have demonstrated bioequivalence among the three LCM formulations (oral tablets, oral solution, and solution for intravenous (IV) infusion), allowing direct conversion to or from oral and IV administration without titration. Thus, the favorable and predictable pharmacokinetic profile and bioequivalence of LCM formulations, coupled with the low potential for clinically relevant pharmacokinetic drug-drug interactions, make LCMan easy-to-use adjunctive treatment for the management of patients with focal epilepsy.
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