Eisai Inc, a US subsidiary of Eisai Co, Ltd, announced that the US Food and Drug Administration (FDA) has accepted to review Eisai's NDA for Banzel (rufinamide) Oral Suspension (40 mg/mL). The proposed indication is for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older and adults. The application is based on data from a study designed to demonstrate the bioequivalence of the oral suspension formulation to the currently marketed Banzel tablet formulation (400 mg).
Acceptance of the NDA indicates that the US FDA has found the company's submission to be sufficiently complete to review. The NDA was submitted to US FDA on April 30, 2010.
The Banzel oral suspension was developed to provide a new option for children over four years and adults who have trouble swallowing tablets.
Banzel is a triazole derivative that is structurally unrelated to currently marketed AEDs. The clinical significance of this structural difference has not been established.