General Information

Banzel is a triazole derivative. The exact mechanism of action is unknown. However, it is thought that rufinamide modulates the activity of sodium channels and, in particular, prolongation of the inactive state of the channel.

Banzel is specifically indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 1 year and older and adults.

Banzel is supplied as a 200mg or 400mg tablet for oral administration.

The recommended initial dose of the drug for pediatrics aged one year and older with Lennox-Gastaut syndrome is a daily dose of approximately 10 mg/kg/day administered in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day to a target dose of 45 mg/kg/day or 3200 mg/day, whichever is less, administered in two equally divided doses.

The recommended initial dose of the drug for adults with Lennox-Gastaut syndrome is a daily dose of 400 to 800 mg/day administered in two equally divided doses. The dose should be increased by 400 to 800 mg/day every 2 days until a maximum daily dose of 3200 mg/day, administered in two equally divided doses is reached.

Clinical Trial Results

FDA approval of Banzel was based on the results of a single clinical trial. This multicenter, double-blind, placebo-controlled, randomized, parallel-group study enrolled 138 subjects, between 4 and 30 years of age, with inadequately controlled seizures associated with LGS. All subjects were being treated with 1 to 3 concomitant stable dose anti-epileptic drugs. After completing a 4-week baseline phase on stable therapy, the subjects were randomized to have Banzel or placebo added to their ongoing therapy during a 12 week double-blind phase. This double-blind phase consisted of two periods: the Titration Period (1 to 2 weeks) and the Maintenance Period (10 weeks). During the Titration Period, the dose was increased to a target dosage of approximately 45 mg/kg/day (3200 mg in adults of > 70kg), given on a twice daily schedule. Final doses at titration were to remain stable during the maintenance period. The median percentage reduction in total seizure frequency from baseline was greater in the rufinamide therapy group than in the placebo group (32.7% versus 11.7%; p<0.002). The rufinamide-treated subjects had 42.5% median percentage reduction in tonic-atonic seizure (drop attack) frequency per 28 days from baseline as compared with 1.4% increase in the placebo-treated subjects (p<0.0001). The rufinamide group had a statistically significant improvement in seizure severity (p<0.005) and a higher percentage of subjects who experienced at least a 50% reduction in tonic-atonic seizure frequency per 28 days compared with placebo (42.5% versus 16.7; p=0.002).