Intravenous brivaracetam safe in paediatric epilepsy

Treatment with intravenous brivaracetam (BRV) is well tolerated in children with epilepsy, with a safety profile consistent with that known of the oral formulation, according to the results of a phase II study. There has been no pharmacokinetic difference observed when administered as bolus or a 15-minute infusion.

The open-label study included 50 patients (mean age 8.3 years, 52 percent boys), among whom 26 (52 percent) received the 15-minute infusion and 24 (48 percent) bolus (≤2-minute injection). Forty-three patients weighed <50 kg, and the rest weighed ≥50 kg. There were no unexpected differences across age cohorts or between the 15-min infusion and bolus groups with respect to demographic characteristics.

Mean duration of epilepsy was 8.2 months in the youngest age cohort (≥1 month to <2 years), 34.6 months in the ≥2 to <6 years cohort, 6.0 years in the ≥6 to <12 years cohort, and 7.9 years in the ≥12 to <16 years cohort. Mean BRV exposure in the respective cohorts was 4.9, 2.9, 3.7, and 4.4 days.

Geometric mean (GeoMean) BRV concentrations in the infusion group were 1,903.0 ng/mL (geometric coefficient of variation [GeoCV]: 60.7 percent) at 15 minutes post dose and 1,130.3 ng/mL (GeoCV: 58.8 percent) at 3 hours post dose. In the bolus group, GeoMean BRV concentrations 15 minutes and 3 hours post dose were 1,704.8 ng/mL (GeoCV: 74.5 percent) and 1,383.9 ng/mL (85.0 percent), respectively.

Fourteen patients (28.0 percent) developed treatment-emergent adverse events (TEAEs; infusion group, 30.8 percent; bolus group, 25.0 percent), with the most common being somnolence (6.0 percent). Meanwhile, drug-related TEAEs occurred in 10 patients (20.0 percent), six of whom were in the infusion group.

None of the patients discontinued treatment due to TEAEs, and no deaths were documented.