Lacosamide partial-onset seizures

Lacosamide is approved as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in patients with... 

Rudd GD, Haverkamp W, Mason JW et al (2015) Lacosamide cardiac safety clinical trials in patients with partial-onset seizures. Acta Neurol Scand 132 355-363 Salk A, Ehrenpreis ED (2016) Attitudes and usage of the Food and Drug Administration Adverse Event Reporting System among gastroenterology nurse practitioners and physician assistants. Gastroenterol Nurs 39 25-31... 

In August 2008, lacosamide was granted market authorization by the European Commission as an adjunctive therapy for partial-onset seizures with or without secondary generalization. It was approved by the FDA as an adjunctive therapy for partial-onset seizures in October 2008 [129 ]. It is also effective against neuropathic pain attributed to distal diabetic neuropathy [130 ]. It is available as oral or intravenous formulations. 

Placebo-controlled studies Lacosamide200, 400, or 600 mg/day has been studied in three randomized, placebo-controlled trials with a 12-week maintenance period, in which about 1300 patients with partial-onset seizures were included [133 ]. There was a statistically significant reduction in 28-day seizure frequency compared with placebo. Lacosamide was generally well tolerated in adult patients with partial-onset seizures, and most treatment-emergent adverse events were of mild or moderate intensity. Dizziness was the most common treatment-related adverse event [134 ]. 

Lacosamide 200 and 400 mg/day as addon therapy in 485 patients with uncontrolled partial-onset seizures has been studied in a multicenter, double-blind, placebo-con-trolled trial, which consisted of an 8-week baseline, a 4-week titration period, and a 12-week maintenance period [137 ]. The median percentage reduction in seizure frequency was 21% for placebo, 35% for lacosamide 200 mg/day, and 36% for 400 mg/ day. The most clearly dose-related treatment-emergent adverse events included dizziness (17 and 25 patients randomized to 200 or 400 mg of lacosamide respectively), nausea (9 and 13 patients), and vomiting (5 and 9 patients). Diplopia (13 and 16 patients) did not appear to be dose-related. The incidence of somnolence was low (4.3%, 3.8%, and 3.7% in patients randomized to lacosamide 200 mg, 400 mg, and placebo respectively). The experimental drug was withdrawn in 42 patients because of adverse effects eight had been randomized to placebo, 10 to lacosamide 200 mg/day, and 24 to 400 mg/day. The adverse effects... 

Harris JA, Murphy JA. Lacosamide an adjunctive agent for partial-onset seizures and potential therapy for neuropathic pain. Ann Pharmacother 2009 43(11) 1809-17. 

Ben-Menachem E, Biton V, Jatuzis D, Abou-Khahl B, Doty P, Rudd GD. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial onset seizures. Epilepsia 2007 48(7) 1308-17. 

Cross SA, Curran MP. Lacosamide in partial-onset seizures. Drugs 2009 69(4) 449-59. 

Haldsz P, Kalviainen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Hebert D, Sulhvan T. SP755 Study Group. Adjunctive lacosamide for partial-onset seizures efficacy and safety results from a randomized controlled trial. Epilepsia 2009 50(3) 443-53. 

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