UCB has presented data from a multi-center trial that supported the potential for adjunctive use of intravenous lacosamide 200-600mg/day using infusion durations as fast as 10 minutes, for short term replacement of oral lacosamide in adult patients with partial onset seizures.
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The study was a, multi-national, open-label trial of 160 patients who were receiving oral lacosamide for at least eight weeks. For the last two weeks of the trial, these patients were on a stable twice daily dosing regimen of lacosamide (200-800mg/day), as well as concomitant antiepileptic drugs with or without vagus nerve stimulation. During the treatment period (two to five days), oral lacosamide was replaced with intravenous lacosamide, infused at a rate of 10, 15 and 30 minutes.
Intravenous lacosamide was generally well-tolerated and the frequency of adverse events did not increase with more days of exposure or shorter infusion durations. The incidence of adverse events was comparable across all infusion durations (10-, 15- and 30-minute infusions), with headache (5%, 7%, 8%) and dizziness (5%, 6%, 8%) being the most commonly reported.
Plasma concentrations were proportional to the actual daily dose given and similar across all infusion duration groups. Intravenous lacosamide was also locally well-tolerated with no serious infusion site reactions. In this study, intravenous lacosamide was administered directly via injection, with no diluent required.
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