Rufinamide is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). It is believed to exert its antiepileptic effects by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures so as to prolong their inactive state.
Eisai said that the drug received approval in Europe in January 2007 and in the US in November 2008 for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in children 4 years and older and adults. It is currently marketed in these regions under the brand names Inovelon and Banzel, respectively.
By moving forward with clinical trials of Rufinamide as a treatment for LGS, Eisai is expected to make further contributions to addressing the diversified needs of and increasing the benefits to patients and their families.
Eisai has been preparing to develop Rufinamide in Japan ever since the Japanese Ministry of Health, Labour and Welfare’s ‘Study Group on Unapproved Drugs,’ the predecessor of the ‘Study Group on Unapproved and Off-label Drugs of High Medical Need,’ recommended that the company begin clinical development of the drug as a treatment for LGS as early as possible.