Eisai Medical Research Inc. has submitted a new drug application (NDA) to the US 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 (12 years of age and over).
Rufinamide is a triazole derivative, a compound structurally distinct from currently approved AEDs. In a multi-centre, 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, according to the company release.
“Rufinamide may be an important breakthrough for Lennox-Gastaut syndrome,” Santiago Arroyo, Medical Director CNS, Eisai Medical Research Inc said adding, “LGS is a serious condition that is difficult to manage with currently approved treatments, and the epilepsy community needs new options.”
Lennox-Gastaut syndrome is a severe form of epilepsy. Seizures usually begin before four years of age, and children with LGS often suffer from several types of seizures. An estimated 1,400 to 4,500 new cases of LGS are diagnosed each year in the US, and complete recovery, including freedom from seizures and normal development, is very unusual. There is no known cure for the disorder.
Eisai acquired exclusive North American and European manufacturing and marketing rights to rufinamide from Novartis Pharma AG in 2004. With the filing of rufinamide, Eisai plans to strengthen its neurology franchise and continue to fulfil its human health care (hhc) mission to satisfy unmet medical needs and increase benefits to patients and their families, the release added.