Comprehensive analyses of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials showing the efficacy and tolerability of Vimpat® (lacosamide) C-V for patients with partial-onset seizures, regardless of the type of concomitant AED used, have been published in the drug evaluation journal, CNS Drugs.
Two key papers have reported that adjunctive lacosamide reduced seizures and improved responder rates compared to placebo, with tolerability data consistent with previous observations in individual trials.
"Analyses of multiple, individual trials with similar design provide a valuable opportunity to evaluate clinically relevant aspects of the resulting large patient pool. These analyses showed the efficacy of lacosamide in combination therapy regardless of the existing AED used and support the use of lacosamide as adjunctive therapy with a broad range of AEDs," commented Dr. Steve Chung, Barrow Neurological Institute, Phoenix, Arizona, US.
Lacosamide (film-coated tablets, syrup and solution for infusion) was launched in the European Union in September 2008, as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older. Lacosamide solution for infusion may be used when oral administration is temporarily not feasible.
In the US, Vimpat® tablets and injection were launched in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are 17 years and older. Lacosamide injection is a short-term replacement when oral administration is not feasible in these patients. Lacosamide oral solution was launched in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent treatment in a hospital setting. The most common adverse reactions occurring in 10 percent or more of lacosamide-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia. Additional important safety information for lacosamide is available at the end of the press release.
The maximum recommended daily dose for Vimpat® in the European Union and the US is 400 mg/day. The 600mg/day dose is not an approved or recommended dose in the European Union or in the US.
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