IV BRV was developed for patients with focal seizures when oral administration is not feasible. Patients with focal seizures in hospital settings taking LEV may require additional treatment to control seizures.

This was a subgroup analysis of a Phase 3, randomized, placebo-controlled trial (N01258; NCT01405508; Klein et al. Epilepsia,2016;57:1130-1138). Randomized patients (aged 16–70 years) initially received BRV oral tablets 200 mg/day or placebo for 7 days, followed by IV BRV 200 mg/day (2-minute bolus or 15-minute infusion) during a 4.5-day Evaluation Period. Treatment-emergent adverse events (TEAEs) were compared between IV BRV+LEV patients and the overall population during the complete oral and IV BRV study period.

Of the 105 patients randomized, 38 (36.2%) were taking concomitant LEV (mean±SD age: 39.7±12.6 years). During the complete study period, TEAEs and drug-related TEAEs in patients treated with IV BRV+LEV were similar to the overall population (TEAEs: 76.3% vs 76.2%; drug-related TEAEs: 65.8% vs 63.8%). One (2.6%) patient on concomitant LEV discontinued due to a TEAE (anxiety). The most common (≥5%) TEAEs in the overall population, somnolence (29.5%), dizziness (14.3%), headache (6.7%), fatigue (5.7%), were reported by 26.3%, 10.5%, 10.5%, and 5.3% IV BRV+LEV-treated patients, respectively. The incidence of individual TEAEs classified as psychiatric or potential behavioral disorders was low (≤3%), with no apparent differences between the IV BRV+LEV-treated patients and the overall population. Four (10.5%) IV BRV+LEV patients had an injection site-related TEAE (overall: 10.5%).

In patients taking concomitant LEV, IV BRV was generally well tolerated with a tolerability profile similar to the overall study population. Therefore, IV BRV may be considered a safe additional treatment option in patients with focal seizures unable to receive oral BRV.