Banzel Mobile Logo A Challenging Form of Epilepsy Seizure Types in LGS LGS Patient Profiles Pivotal Trial Design Efficacy of BANZEL® in Seizure Reduction Seizure Severity Rating Responder Rates Adverse Reactions Mechanism of Action/Pharmacokinetics Dosing

BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults.

Prescribing Information Important Safety Information For Patients

SIGNIFICANT RESPONDER RATES IN REDUCTION
OF TOTAL SEIZURES

Nearly 3 times the percent of patients in the BANZEL® group experienced a ≥50% reduction in total seizures compared with that in the placebo group

Patients achieving ≥50% reduction in total seizure frequency per 28 days relative to baseline*1

BANZEL (rufinamide) Efficacy Chart showing that nearly 3 times the percent of patients in the BANZEL group experienced a ≥50% reduction in total seizure frequency per 28 days relative to baseline. 31.1% of BANZEL patients showed a ≥50% reduction in total seizures compared to 10.9% of the placebo patients (P<0.005). This was a secondary efficacy endpoint in the pivotal trial. BANZEL (rufinamide) Efficacy Chart showing that nearly 3 times the percent of patients in the BANZEL group experienced a ≥50% reduction in total seizure frequency per 28 days relative to baseline. 31.1% of BANZEL patients showed a ≥50% reduction in total seizures compared to 10.9% of the placebo patients (P<0.005). This was a secondary efficacy endpoint in the pivotal trial.

*Secondary efficacy endpoint.

  • A secondary efficacy endpoint, defined as percentage of patients with at least 50% reduction in total seizure
    frequency per 28 days during the double-blind treatment phase relative to baseline
  • Results vs placebo were statistically significant

SIGNIFICANT RESPONDER RATES IN REDUCTION OF TONIC-ATONIC SEIZURES (DROP ATTACKS)

Patients who experienced a ≥50% or ≥75% reduction in tonic-atonic seizures from baseline (per 28 days)1,3

BANZEL (rufinamide) Efficacy Chart showing a significant responder rates in the reduction of tonic-atonic seizures (drop attacks). This chart shows the percentage of patient who experienced a ≥50% or ≥75% reduction in tonic-atonic seizures from baseline (per 28 days): 42.5% of BANZEL patients taking 1-3 AEDs showed a ≥50% reduction vs 16.7% of placebo patients taking 1-3 AEDs (P=0.002) while 21.9% of BANZEL patients versus 3.3 of placebo patients showed a ≥75% reduction (P<0.007) The ≥50% reduction was a secondary efficacy endpoint in the pivotal trial. BANZEL (rufinamide) Efficacy Chart showing a significant responder rates in the reduction of tonic-atonic seizures (drop attacks). This chart shows the percentage of patient who experienced a ≥50% or ≥75% reduction in tonic-atonic seizures from baseline (per 28 days): 42.5% of BANZEL patients taking 1-3 AEDs showed a ≥50% reduction vs 16.7% of placebo patients taking 1-3 AEDs (P=0.002) while 21.9% of BANZEL patients versus 3.3 of placebo patients showed a ≥75% reduction (P<0.007) The ≥50% reduction was a secondary efficacy endpoint in the pivotal trial.

*Secondary efficacy endpoint.

  • Results vs placebo were statistically significant
  • References: 1. Glauser et al. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology. 2008;70(21):1950-1958. 2. BANZEL® (rufinamide) prescribing information, Eisai Inc. 3. Data on file, Eisai Inc.
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Plus icon Pivotal Trial Design Information
  • A 12-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial to assess the effectiveness of BANZEL (rufinamide) to reduce inadequately controlled seizures associated with LGS in patients (N=138, intent to treat) being treated with 1-3 concomitant stable-dose AEDs1-3
  • The primary efficacy variables were the percent change in total seizure frequency per 28 days, the percent change in tonic-atonic (drop attacks) seizure frequency per 28 days, and the seizure severity rating from the parent/guardian global evaluation of the patient's condition1
  • All 3 primary endpoints met the prespecified statistical criteria for effectiveness1
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ADVERSE REACTIONS ►

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(adverse events)
profile of BANZEL®