Diazepam buccal film OK'ed for pediatric seizure clusters

FDA has approved diazepam buccal film (Libervant) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 to 5 years of age. Approval was based on studies of diazepam rectal gel in adult and pediatric patients, adult bioavailability studies comparing Libervant with diazepam rectal gel, adult and pediatric Libervant pharmacokinetic data, and an open-label safety study of Libervant including patients 2 to 5 years of age.