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Home » EISAI SUBMITS APPLICATION FOR ANTI-EPILEPTIC DRUG
EISAI SUBMITS APPLICATION FOR ANTI-EPILEPTIC DRUG
September 13, 2005
Eisai Medical Research has submitted a new drug application to the FDA for the anti-epileptic drug (AED) rufinamide. Eisai is seeking approval for two indications for rufinamide, as adjunctive therapy for Lennox-Gastaut syndrome (LGS) in children ages four and over and as adjunctive therapy for partial-onset seizures with and without secondary generalization in adults and adolescents.
Rufinamide is a triazole derivative, a compound structurally distinct from currently approved AEDs. In a multicenter, double-blind, placebo-controlled clinical trial, rufinamide was shown to have clinical benefit in the treatment of seizures associated with LGS, a severe form of epilepsy that develops in early childhood, and was designated as an orphan drug for this indication by the FDA in October 2004. Based on key findings of two double-blind, placebo-controlled trials, rufinamide will also be filed with the FDA as adjunctive therapy in adults and adolescents, 12 years of age and over, with partial-onset seizures with and without secondary generalization.
KEYWORDS Drug Pipeline Alert
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