Rufinamide Designated by the FDA as Orphan Drug
for Lennox-Gastaut Syndrome
RIDGEFIELD PARK, N.J., Sept. 13 /PRNewswire/ -- Eisai Medical Research
Inc. (Headquarters: Ridgefield Park, President Mindell Seidlin, M.D.) has
submitted a new drug application (NDA) to the U.S. Food and Drug
Administration (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 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.
"Rufinamide may be an important breakthrough for Lennox-Gastaut syndrome,"
said Santiago Arroyo, MD, PhD, Medical Director CNS, Eisai Medical Research
Inc. "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 U.S., and complete recovery, including freedom from
seizures and normal development, is very unusual. There is no known cure for
the disorder.
Rufinamide also was shown to have clinical benefit as adjunctive therapy
in treating adults and adolescents (12 years of age and over) with partial-
onset seizures with or without secondary generalization. Partial seizures
affect only one area of the brain and are the most common type of seizure
experienced by people with epilepsy.
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 fulfill its human health care (hhc) mission to satisfy unmet
medical needs and increase benefits to patients and their families.
In double-blind studies, the most commonly observed adverse experiences
seen in association with rufinamide and at a higher frequency (greater than or
equal to 10%) than in placebo-treated patients were headache, dizziness,
fatigue, somnolence and nausea.
About Eisai Medical Research Inc.
Eisai Medical Research Inc. is a U.S. pharmaceutical subsidiary of Eisai
Co., Ltd. Eisai Medical Research Inc. was established to focus solely on
clinical research and to expedite clinical drug development of new chemical
entities and of new indications for marketed products.
SOURCE Eisai Medical Research
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Related links:
http://www.eisai.com
CONTACT:
Judee Shuler, +1-201-287-2241, or
Judee_Shuler@eisai.com; or Krysta Pellegrino, +1-415-262-5211, or
kpellegrino@dorland.com, for Eisai Medical Research Inc.
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