The agency approved Eisai’s Inovelon (rufinamide) as an adjunctive therapy to other antiepileptic drugs in the treatment of Lennox-Gastaut syndrome
Rufinamide is an anticonvulsant medication. It is used in combination with other medication and therapy to treat Lennox–Gastaut syndrome and various other seizure disorders. Rufinamide, a triazole derivative, was developed in 2004 by Novartis Pharma, AG, and is manufactured by Eisai.
Rufinamide was approved by the US Food and Drug Administration on November 14, 2008 as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults. Its official FDA-approved labeling does not mention use in the treatment of partial seizures inasmuch as clinical trials submitted to the FDA were marginal. However, several recent clinical trials suggest that the drug has efficacy for partial seizures It is marketed under the brand name Banzel. It is also marketed in the European Union under the brand name Inovelon.
The mechanism of action of rufinamide is unknown. However, it is presumed to involve stabilization of the sodium channel inactive state, effectively keeping these ion channels closed. Although the direct mechanism of action may be different, several other antiepileptic agents also stabilize a sodium channel inactive state including phenytoin, carbamazepine, and lacosamide (stabilizes the slow inactive state).