General Information

Briviact (brivaracetam) displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism by which Briviact exerts its anticonvulsant activity is not known.

Briviact is specifically indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 1 month of age and older with epilepsy.

Briviact is supplied in three formulations: tablet, oral solution and injection for intravenous administration. Recommended dosing is as follows:

Monotherapy or Adjunctive Therapy

The recommended dosage for patients 1 month of age and older is included in the table below. In pediatric patients weighing less than 50 kg, the recommended dosing regimen is dependent upon body weight. When initiating treatment, gradual dose escalation is not required. Dosage should be adjusted based on clinical response and tolerability.

Age and Body Weight

Initial Dosage

Minimum and Maximum Maintenance Dosage

Adults (16 years and older)

50 mg twice daily (100 mg per day)

25 mg to 100 mg twice daily (50 mg to 200 mg per day)

Pediatric patients weighing 50 kg or more

25 mg to 50 mg twice daily (50 mg to 100 mg per day)

25 mg to 100 mg twice daily (50 mg to 200 mg per day)

Pediatric patients weighing 20 kg to less than 50 kg

0.5 mg/kg to 1 mg/kg twice daily (1 mg/kg to 2 mg/kg per day)

0.5 mg/kg to 2 mg/kg twice daily (1 mg/kg to 4 mg/kg per day)

Pediatric patients weighing 11 kg to less than 20 kg

0.5 mg/kg to 1.25 mg/kg twice daily (1 mg/kg to 2.5 mg/kg per day)

0.5 mg/kg to 2.5 mg/kg twice daily (1 mg/kg to 5 mg/kg per day)

Pediatric patients weighing less than 11 kg

0.75 mg/kg to 1.5 mg/kg twice daily (1.5 mg/kg to 3 mg/kg per day)

0.75 mg/kg to 3 mg/kg twice daily (1.5 mg/kg to 6 mg/kg per day)

Briviact Injection Dosage

Briviact injection may be used when oral administration is temporarily not feasible. Briviact injection should be administered intravenously at the same dosage and same frequency as Briviact tablets and oral solution. The clinical study experience with Briviact injection is up to 4 consecutive days of treatment.

Clinical Trial Results

The FDA approval of Briviact was based on pooled data from three pivotal Phase III studies (N01252, N01253 and N01358). The fixed-dose, randomized, double-blind, placebo-controlled, multicenter studies enrolled 1,550 patients with partial-onset seizures that were not adequately controlled with 1 to 2 concomitant antiepileptic drugs. All trials had an 8-week baseline period, during which patients were required to have at least 8 partial-onset seizures. The baseline period was followed by a 12-week treatment period. There was no titration period in these studies. Study 1 compared doses of Briviact 50 mg/day and 100 mg/day with placebo. Study 2 compared a dose of Briviact 50 mg/day with placebo. Study 3 compared doses of Briviact 100 mg/day and 200 mg/day with placebo. Briviact demonstrated statistically significant reductions over placebo in partial-onset seizure frequency per 28 days (19.5%, 24.4% and 24.0% for Briviact 50, 100 and 200 mg/day respectively). The proportion of patients showing a 50% or greater reduction in partial-onset seizure frequency was 34.2% (50 mg/day), 39.5% (100 mg/day) and 37.8% (200 mg/day), vs. 20.3% for placebo.