Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 10 mg, 25 mg, 50 mg, 75 mg, 100 mg); solution (oral; 10 mg/mL); injection (intravenous; 50 mg/ 5 mL) |
Drug Class | Anticonvulsants |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Latest News
Summary
- Briviact (brivaracetam) is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
- This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
- Reduction in Seizure Frequency: Brivaracetam (BRV) significantly reduced seizure frequency in multiple studies, with a 35% responder rate (≥50% reduction) and an 18% seizure freedom rate in children. In adults, BRV showed a 50% responder rate (RR 1.88) and a seizure freedom rate (RR 5.82) for focal onset seizures. However, it was less effective compared to cenobamate (CNB) and eslicarbazepine acetate (ESL) in achieving ≥50% seizure frequency reduction.
- Seizure Freedom: BRV add-on therapy demonstrated a significant risk ratio (RR 5.89) for seizure freedom according to the Cochrane Review, although the certainty of evidence was low.
- Comparative Efficacy: BRV was more effective than placebo in reducing seizure frequency but was less effective than CNB and ESL. CNB ranked highest in efficacy for both ≥50% and 100% seizure reduction.
- Population Differences: In children, BRV achieved a 35% responder rate and an 18% seizure freedom rate. In adults with drug-resistant epilepsy, BRV was effective in reducing seizures but was associated with a higher rate of treatment withdrawal due to adverse events.
- Adverse Events (AEs): BRV showed a TEAE incidence of 66.9%, with somnolence, headache, dizziness, and fatigue being the most common. In children, the incidence of TEAEs was 39%, with somnolence (9%) and mental/behavioral disorders (12%) as the most frequent.
- Psychiatric and Behavioral Disorders: BRV had an 11.3% incidence of psychiatric AEs compared to 8.2% with placebo. Behavioral AEs, such as irritability (2.7%) and aggression/psychosis (≤1%), were relatively low.
- Withdrawal Due to AEs: There was a higher withdrawal rate due to AEs with BRV (RR 1.54) compared to placebo.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Briviact (brivaracetam) Prescribing Information. | 2023 | UCB, Inc., Smyrna, GA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Epilepsies in children, young people and adults. | 2022 | NICE |
Clinical guidelines for the management of epilepsy. | 2020 | The Epilepsy Research Program of the Ontario Brain institute |