To compare plasma exposures from diazepam buccal film (DBF) administered in children with epilepsy under periictal or interictal conditions.

Diazepam buccal film (DBF) is a novel diazepam dosage form for treating acute repetitive seizures. This study compares diazepam exposures obtained when DBF is administered to children in either the periictal state (during a seizure or less than 5 min from seizure cessation) or interictal state (between seizures).

Twenty-four patients received at least one dose of study drug; 17 in the interictal period and 16 in the periictal period, with 9 subjects dosed in both periods. Diazepam least square mean maximum plasma concentrations were somewhat higher in the interictal state than in the periictal state, but these differences were not statistically significant. There was no difference in the median time to maximum diazepam concentration when patients were dosed in either seizure state.

Even if DBF is administered in close proximity to a seizure, the maximum plasm diazepam concentration achieved is comparable to that observed when DBF is dosed in between seizures. Likewise, the speed of diazepam absorption is not affected by dosing DBF either during or between seizures. DBF provides a convenient way to deliver diazepam for the treatment of acute repetitive seizure emergencies in children.