In this 160-patient analysis of the lacosamide long-term open-label extension trial, patients receiving oral lacosamide were converted to therapeutically equivalent intravenous doses, and grouped into three cohorts based on infusion duration. Results showed that intravenous lacosamide provided similar plasma concentrations as those associated with oral lacosamide, across consecutive dosing days and regardless of infusion durations.
Average Ctrough and Cmax plasma concentrations (minimum and maximum concentrations of a drug in the body after dosing) for oral and intravenous lacosamide appeared dose-proportional across consecutive dosing days within a therapeutic dose range. Plasma concentration levels were similar across all cohorts.Abstract: A multicenter, open-label trial to assess the safety and tolerability of a single intravenous loading dose of lacosamide followed by oral maintenance as adjunctive therapy in subjects with partial-onset seizures: an interim reportIn this study, patients currently taking one to two AEDs were grouped into three, 25-patient cohorts and given three progressively increasing doses of intravenous lacosamide (200 mg, 300 mg and 400 mg) administered via 15-minute infusions, followed by the same dose of the oral form given twice-daily for 6.5 days.
The first three cohorts (200 mg, 300 mg and 400 mg loading dose) have completed the trial. All subjects in the first cohort (200 mg loading dose) completed the trial. One subject (4 percent) from the second cohort (300 mg loading dose) and four subjects (16 percent) from the third cohort (400 mg loading dose) withdrew due to adverse events.
Based on results of these cohorts, enrollment of the fourth repeat cohort will proceed with the highest well-tolerated loading dose. Additional data on safety and tolerability will be presented during the poster session at AES.
SOURCE UCB