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New Indication for Anti-Epileptic Drug Lacosamide (Vimpat)
The FDA has given the nod to a supplemental new drug application for lacosamide (Vimpat, UCB) as monotherapy for the treatment of partial-onset seizures in patients aged 17 years and older with epilepsy. The drug is already approved in the U.S. as adjunctive treatment for partial-onset seizures in this age group.
The new indication means that adults with partial-onset seizures can be initiated on lacosamide monotherapy, and that patients already being treated with an anti-epileptic drug can be converted to lacosamide monotherapy.
The FDA also approved a new single-loading dose-administration option for all formulations of lacosamide when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients aged 17 years and older with epilepsy.
The new approval of lacosamide as monotherapy was based on a phase III historical-control conversion to lacosamide monotherapy study in adult epilepsy patients with partial-onset seizures. The study met its primary endpoint, demonstrating that the exit percentage (defined as the estimated percentage of patients meeting predefined exit criteria) for patients converting to lacosamide 400 mg/day was significantly lower than the historical control exit percentage, used as a comparator. Lacosamide 300 mg/day also met the prespecified criteria for efficacy.
The most common adverse events were similar to those seen in adjunctive-therapy studies; however, one adverse reaction — insomnia — was observed at a rate of 2% or more and was not reported at a similar rate in previous studies. Insomnia has also been observed in post-marketing experience. Because this study did not include a placebo control group, causality could not be established. In adjunctive-therapy studies, the most common adverse events (10% or more and greater than placebo) were dizziness, headache, nausea, and diplopia.
The new dose-administration option for lacosamide as monotherapy or adjunctive treatment of partial-onset seizures in adults with epilepsy allows initiation of the drug as a single-loading dose of 200 mg (oral or injection), followed approximately 12 hours later by a 100-mg twice-daily dose (200 mg/day). The most common loading-dose adverse events (5% or more) were dizziness, headache, paresthesia, and gait disturbance.
The loading dose should be administered with medical supervision in view of the pharmacokinetics of lacosamide and the increased incidence of central nervous system adverse reactions.
Source: UCB; September 1, 2014.