Libervant Buccal Film Receives FDA Approval for Seizure Treatment

Aquestive Therapeutics (Warren, NJ) announced that the Food and Drug Administration (FDA) has approved Libervant (diazepam buccal film) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) in patients with epilepsy aged 2 to 5 years. Libervant is available in 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg formulations.  Prescribing information for Libervant includes a boxed warning about risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions. 

"Libervant provides a new way to deliver diazepam for the treatment of acute repetitive seizure emergencies in children aged two to five," said Michael Rogawski, MD, PhD, Distinguished Professor of Neurology and Pharmacology at the University of California, Davis. "Studies show that the film is easy to administer and performs reliably in children as young as 2 years of age."