Pharmacokinetic drug evaluation of lacosamide for the treatment of partial-onset seizures

References

• de Boer HM, Mula M, Sander JW. The global burden and stigma of epilepsy. Epilepsy Behav. 2008;12(4):540–546.
   PubMed Web of Science ®Google Scholar
• Shneker BF, Fountain NB. Epilepsy. Dis Mon. 2003;49(7):426–478.
   PubMed Web of Science ®Google Scholar
• de Biase S, Gigli GL, Valente M, et al. Lacosamide for the treatment of epilepsy. Expert Opin Drug Metab Toxicol. 2014;10(3):459–468.
   PubMed Web of Science ®Google Scholar
• Paquette V, Culley C, Greanya ED, et al. Lacosamide as adjunctive therapy in refractory epilepsy in adults: a systematic review. Seizure. 2015;25:1–17.
   PubMed Web of Science ®Google Scholar
• Bialer M, White HS. Key factors in the discovery and development of new antiepileptic drugs. Nat Rev Drug Discov. 2010;9(1):68–82.
   PubMed Web of Science ®Google Scholar
• US FDA. Vimpat ® (lacosamide): highlights of prescribing information. [cited 2017 Apr 10]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf
   Google Scholar
• European Medicines Agency. Lacosamide: summary of product characteristics. [cited 2017 Apr 10]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000863/WC500050338.pdf
   Google Scholar
• Hovinga CA. SPM-927 (Schwarz Pharma). IDrugs. 2003;6(5):479–485.
   PubMed Web of Science ®Google Scholar
• Beyreuther BK, Freitag J, Heers C, et al. Lacosamide: a review of preclinical properties. CNS Drug Rev. 2007;13(1):21–42.
   PubMedGoogle Scholar
• Kellinghaus C. Lacosamide as treatment for partial epilepsy: mechanisms of action, pharmacology, effects, and safety. Ther Clin Risk Manag. 2009;5:757–766.
   PubMedGoogle Scholar
• Rogawski MA, Tofighy A, White HS, et al. Current understanding of the mechanism of action of the antiepileptic drug lacosamide. Epilepsy Res. 2015;110:189–205.
   PubMed Web of Science ®Google Scholar
• Hoy S. Lacosamide: a review of its use as adjunctive therapy in the management of partial-onset seizures. CNS Drugs. 2013;27(12):1125–1142.
   PubMed Web of Science ®Google Scholar
• Wolff C, Carrington B, Varrin-Doyer M, et al. Drug binding assays do not reveal specific binding of lacosamide to collapsin response mediator protein 2 (CRMP-2). CNS Neurosci Ther. 2012;18(6):493–500.
   PubMed Web of Science ®Google Scholar
• Cawello W, Kropeit D, Schiltmeyer B, et al. Food does not affect the pharmacokinetics of SPM 927. Epilepsia. 2004;45(Suppl.7):307.
   Google Scholar
• Cawello W, Stockis A, Andreas JO, et al. Advances in epilepsy treatment: lacosamide pharmacokinetic profile. Ann NY Acad Sci. 2014;1329:18–32.
   PubMed Web of Science ®Google Scholar
• Fountain NB, Krauss G, Isojarvi J, et al. Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures. Epilepsia. 2013;54(1):58–65.
   PubMed Web of Science ®Google Scholar
• Horstmann R, Bonn R, Cawello W, et al. Basic clinical pharmacological investigations of the new antiepileptic drug SPM 927. Epilepsia. 2002;43(Suppl.7):188.
   Google Scholar
• Ben Menachem E, Biton V, Jatuzis D, et al. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007;48(7):1308–1317.
   PubMed Web of Science ®Google Scholar
• Halasz P, Kalviainen R, Mazurkiewicz-Beldzinska M, et al. Adjunctive lacosamide for partial-onset seizures: efficacy and safety results from a randomized controlled trial. Epilepsia. 2009;50(3):443–453.
   PubMed Web of Science ®Google Scholar
• Chung S, Sperling MR, Biton V, et al. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010;51(6):958–967.
   PubMed Web of Science ®Google Scholar
• Kropeit D, Schiltmeyer B, Cawello W, et al. Bioequivalence of short-time infusions compared to oral administration of SPM 927. Epilepsia. 2004;45(Suppl.7):123–124.
   Google Scholar
• Biton V, Rosenfeld WE, Whitesides J, et al. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008;49(3):418–424.
   PubMed Web of Science ®Google Scholar
• Bialer M, Johannessenb SI, Levyc RH, et al. Progress report on new antiepileptic drugs: a Summary of the Ninth Eilat Conference (EILAT IX). Epilepsy Res. 2009;83(1):1–43.
   PubMed Web of Science ®Google Scholar
• Cawello W, Bökens H, Nickel B, et al. Tolerability, pharmacokinetics, and bioequivalence of the tablet and syrup formulations of lacosamide in plasma, saliva, and urine: saliva as a surrogate of pharmacokinetics in the central compartment. Epilepsia. 2013;54(1):81–88.
   PubMed Web of Science ®Google Scholar
• Fountain N, Staelens L, Tytgat D, et al. Low lacosamide plasma protein binding in lacosamide-naive patients. Neurology. 2012;78:P01.077.
   Web of Science ®Google Scholar
• Drobitch RK, Svensson CK. Therapeutic drug monitoring in saliva. An update. Clin Pharmacokinet. 1992;23(5):365–379.
   PubMed Web of Science ®Google Scholar
• Michelhaugh SK, Basha M, Rhoney DH, et al. Acute or chronic use of lacosamide does not alter its distribution between serum and cerebrospinal fluid. Epilepsia. 2015;56(11):1732–1737.
   PubMed Web of Science ®Google Scholar
• May TW, Brandt C, Helmer R, et al. Comparison of lacosamide concentrations in cerebrospinal fluid and serum in patients with epilepsy. Epilepsia. 2015;56(7):1134–1140.
   PubMed Web of Science ®Google Scholar
• Cawello W, Boekens H, Bonn R. Absorption, disposition, metabolic fate and elimination of the anti-epileptic drug lacosamide in humans: mass balance following intravenous and oral administration. Eur J Drug Metab Pharmacokinet. 2012;37(4):241–248.
   PubMed Web of Science ®Google Scholar
• Thomas D, Scharfenecker U, Schiltmeyer B, et al. Low potential for drug-drug-interaction of lacosamide. Eur J Pain. 2006;10(Suppl.1):S167–S168.
   PubMedGoogle Scholar
• Errington AC, Stöhr T, Heers C, et al. The investigational anticonvulsant lacosamide selectively enhances slow inactivation of voltage-gated sodium channels. Mol Pharmacol. 2008;73(1):157–169.
   PubMed Web of Science ®Google Scholar
• Gidal BE. Drug absorption in the elderly: biopharmaceutical considerations for the antiepileptic drugs. Epilepsy Res. 2006;68(Suppl.1):S65–S69.
   PubMed Web of Science ®Google Scholar
• Schaefer C, Cawello W, Waitzinger J, et al. Effect of age and sex on lacosamide pharmacokinetics in healthy adult subjects and adults with focal epilepsy. Clin Drug Investig. 2015;35(4):255–265.
   PubMed Web of Science ®Google Scholar
• Cawello W, Fuhr U, Hering U, et al. Impact of impaired renal function on the pharmacokinetics of the antiepileptic drug lacosamide. Clin Pharmacokinet. 2013;52(10):897–906.
   PubMed Web of Science ®Google Scholar
• Husain A, Chung S, Faught E, et al. Long-term and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012;53(3):521–528.
   PubMed Web of Science ®Google Scholar
• Rosenfeld W, Fountain NB, Kaubrys G, et al. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014;41:164–170.
   PubMed Web of Science ®Google Scholar
• Runge U, Arnold S, Brandt C, et al. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: the VITOBA study. Epilepsia. 2015;56(12):1921–1930.
   PubMed Web of Science ®Google Scholar
• Villanueva V, Lopez-Gomariz E, Lopez-Trigo J, et al. Rational polytherapy with lacosamide in clinical practice: results of a Spanish cohort analysis RELACOVA. Epilepsy Behav. 2012;23(3):298–304.
   PubMed Web of Science ®Google Scholar
• Gavatha M, Ionnou I, Papavasiliou AS. Efficacy and tolerability of oral lacosamide as adjunctive therapy in pediatric patients with pharmacoresistant focal epilepsy. Epilepsy Behav. 2011;20(4):691–693.
   PubMed Web of Science ®Google Scholar
• Guilhoto LM, Loddenkemper T, Gooty VD, et al. Experience with lacosamide in a series of children with drug-resistant focal epilepsy. Pediatr Neurol. 2011;44(6):414–419.
   PubMed Web of Science ®Google Scholar
• Heyman E, Lahat E, Levin N, et al. Preliminary efficacy and safety of lacosamide in children with refractory epilepsy. Eur J Paediatr Neurol. 2012;16(1):15–19.
   PubMed Web of Science ®Google Scholar
• Rastogi RG, Ng Y. Lacosamide in refractory mixed pediatric epilepsy: a prospective add-on study. J Child Neurol. 2012;27(4):492–495.
   PubMed Web of Science ®Google Scholar
• Casas-Fernandez C, Martınez-Bermejo A, Rufo-Campos M, et al. Efficacy and tolerability of lacosamide in the concomitant treatment of 130 patients under 16 years of age with refractory epilepsy: a prospective, open-label, observational, multicenter study in Spain. Drugs R D. 2012;12(4):187–197.
   PubMedGoogle Scholar
• Verrotti A, Loiacono G, Pizzolorusso A, et al. Lacosamide in pediatric and adult patients: comparison of efficacy and safety. Seizure. 2013;22(3):210–216.
   PubMed Web of Science ®Google Scholar
• Grosso S, Parisi P, Spalice A, et al. Efficacy and safety of lacosamide in infants and young children with refractory focal epilepsy. Eur J Paediatr Neurol. 2014;18(1):55–59.
   PubMed Web of Science ®Google Scholar
• Wechsler RT, Li G, French J, et al. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014;55(7):1088–1098.
   PubMed Web of Science ®Google Scholar
• French JA, Wang S, Warnock B, et al. Historical control monotherapy design in the treatment of epilepsy. Epilepsia. 2010;51(10):1936–1943.
   PubMed Web of Science ®Google Scholar
• Baulac M, Rosenow F, Toledo M, et al. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2017;16(1):43–54.
   PubMed Web of Science ®Google Scholar
• Höfler J, Trinka E. Lacosamide as a new tratment option in status epilepticus. Epilepsia. 2013;54(3):393–404.
   PubMed Web of Science ®Google Scholar
• Legros B, Depondt C, Levy-Nogueira M, et al. Intravenous lacosamide in refractory seizure clusters and status epilepticus: comparison of 200 and 400 mg loading doses. Neurocrit Care. 2014;20(3):484–488.
   PubMed Web of Science ®Google Scholar
• Kellinghaus C, Berning S, Stögbauer F. Intravenous lacosamide or phenytoin for treatment of refractory status epilepticus. Acta Neurol Scand. 2014;129(5):294–299.
   PubMed Web of Science ®Google Scholar
• Zaccara G, Perucca P, Loiacono G, et al. The adverse event profile of lacosamide: a systematic review and meta-analysis of randomized controlled trials. Epilepsia. 2013;54(1):66–74.
   PubMed Web of Science ®Google Scholar
• Zaccara G, Giovannelli F, Maratea D, et al. Neurological adverse events of new generation sodium blocker antiepileptic drugs. Meta-analysis of randomized, double-blinded studies with eslicarbazepine acetate, lacosamide and oxcarbazepine. Seizure. 2013;22(7):528–536.
   PubMed Web of Science ®Google Scholar
• Cawello W. Clinical pharmacokinetic and pharmacodynamic profile of lacosamide. Clin Pharmacokinet. 2015;54(9):901–914.
   PubMed Web of Science ®Google Scholar
• Cawello W, Mueller-Voessing C, Fichtner A. Pharmacokinetics of lacosamide and omeprazole coadministration in healthy volunteers: results from a phase I, randomized, crossover trial. Clin Drug Investig. 2014;34(5):317–325.
   PubMed Web of Science ®Google Scholar
• Cross SA, Curran MP. Lacosamide: in partial-onset seizures. Drugs. 2009;69(4):449–459.
   PubMed Web of Science ®Google Scholar
• Contin M, Albani F, Riva R, et al. Lacosamide therapeutic monitoring in patients with epilepsy: effect of concomitant antiepileptic drugs. Ther Drug Monit. 2013;35(6):849–852.
   PubMed Web of Science ®Google Scholar
• Markoula S, Teotonio R, Ratnaraj N, et al. Lacosamide serum concentrations in adult patients with epilepsy: the influence of gender, age, dose, and concomitant antiepileptic drugs. Ther Drug Monit. 2014;36(4):494–498.
   PubMed Web of Science ®Google Scholar
• Svendsen T, Brodtkorb E, Baftiu A, et al. Therapeutic drug monitoring of lacosamide in Norway: focus on pharmacokinetic variability, efficacy and tolerability. Neurochem Res. 2017;42(7):2077–2083.
   PubMed Web of Science ®Google Scholar
• Cawello W, Nickel B, Eggert-Formella A. No pharmacokinetic interaction between lacosamide and carbamazepine in healthy volunteers. J Clin Pharmacol. 2010;50(4):459–471.
   PubMed Web of Science ®Google Scholar
• Novy J, Patsalos PN, Sander JW, et al. Lacosamide neurotoxicity associated with concomitant use of sodium channel-blocking antiepileptic drugs: a pharmacodynamic interaction? Epilepsy Behav. 2011;20(1):20–23.
   PubMed Web of Science ®Google Scholar
• Edwards HB, Cole AG, Griffiths AS, et al. Minimizing pharmacodynamic interactions of high doses of lacosamide. Acta Neurol Scand. 2012;125(4):228–233.
   PubMed Web of Science ®Google Scholar
• Stein MA, Kanner AM. Management of newly diagnosed epilepsy: a practical guide to monotherapy. Drugs. 2009;69(2):199–222.
   PubMed Web of Science ®Google Scholar
• Chung S, Wang N, Hank N. Comparative retention rates and long-term tolerability of new antiepileptic drugs. Seizure. 2007;16(4):296–304.
   PubMed Web of Science ®Google Scholar
• Chung SS. New treatment option for partial-onset seizures: efficacy and safety of lacosamide. Ther Adv Neurol Disord. 2010;3(2):77–83.
   PubMedGoogle Scholar
• Sake J-K, Hebert D, Isojarvi J, et al. A pooled analysis of lacosamide clinical trial data grouped by mechanism of action of concomitant antiepileptic drugs. CNS Drugs. 2010;24(12):1055–1068.
   PubMed Web of Science ®Google Scholar