BANZEL® DEMONSTRATED POWERFUL, BROAD SPECTRUM EFFICACY IN THE REDUCTION OF TOTAL SEIZURES

Median percent reduction in total seizure
frequency per 28 days relative to baseline*1,2

BANZEL (rufinamide) Efficacy Chart showing the median percent reduction in total seizure frequency per 28 days relative to baseline. BANZEL showed a 32.7% reduction in the number of total seizures (per 28 days relative to baseline) versus 11.7% reduction in the placebo group. This showed a statistical significance of P<0.002. The median percent reduction in total seizure frequency per 28 days relative to baseline was a primary efficacy endpoint of the pivotal trial. BANZEL (rufinamide) Efficacy Chart showing the median percent reduction in total seizure frequency per 28 days relative to baseline. BANZEL showed a 32.7% reduction in the number of total seizures (per 28 days relative to baseline) versus 11.7% reduction in the placebo group. This showed a statistical significance of P<0.002. The median percent reduction in total seizure frequency per 28 days relative to baseline was a primary efficacy endpoint of the pivotal trial.
Seizure types in the trial population Seizure types in the trial population

*Primary efficacy endpoint.

Percentage of trial patients with specific seizures at baseline1,3

Shows the percentage of BANZEL trial patient with specific seizures at baseline. There were 99% of BANZEL patients that experienced tonic –atonic seizures compared to 94% of placebo patients; 80% of BANZEL patients vs 86% placebo for atypical absence; 70% of BANZEL patients vs 67% experienced tonic seizures; 61% of BANZEL patients vs 52% of placebo patients experienced atonic seizures; 50% of BANZEL patients versus 48% of placebo patients experienced myoclonic  seizures; 50% of BANZEL patients vs 42% of placebo patients experienced tonic-clonic seizures; 16% of BANZEL patients experienced unclassified seizures compared to 20% of placebo patients; 15% of BANZEL patients experienced partial seizures compared to 14% of placebo patients; 11% of BANZEL patients experienced absence seizures compared to 8% of placebo patients; and 9% of BANZEL patients experienced clonic seizures compared to 2% of placebo patients.

Adjunctive treatment with BANZEL® achieved a nearly three-fold median percent reduction in total seizures vs placebo

  • 32.7% and 11.7% for BANZEL and placebo, respectively (P<0.002)
  • Results vs placebo were statistically significant
 

Powerful efficacy in the reduction of tonic-atonic seizures (drop attacks)

Median percent reduction in tonic-atonic seizure frequency per 28 days relative to baseline*1,2

BANZEL (rufinamide) Efficacy Chart showing the median percent reduction in tonic-atonic seizure frequency per 28 days relative to baseline. BANZEL showed a 42.5% reduction in drop attacks in the BANZEL group vs a 1.4% increase in the placebo group (P<0.0001). This was a primary efficacy endpoint in the pivotal trial. BANZEL (rufinamide) Efficacy Chart showing the median percent reduction in tonic-atonic seizure frequency per 28 days relative to baseline. BANZEL showed a 42.5% reduction in drop attacks in the BANZEL group vs a 1.4% increase in the placebo group (P<0.0001). This was a primary efficacy endpoint in the pivotal trial.

*Primary efficacy endpoint.

A 42.5% reduction in drop attacks in the BANZEL® group vs a 1.4% increase in the placebo group (P<0.0001)

  • A primary efficacy endpoint, defined as percent change in the frequency of tonic-atonic (the sum of tonic and atonic seizures) per 28 days during the double-blind treatment phase
  • 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.
 
  • 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