Posted by Michael Wonder on 03 Dec 2019
Aquestive Therapeutics completes rolling submission of new drug application to U.S. Food and Drug Administration for Libervant (diazepam) buccal film for management of seizure clusters
2 December 2019 - Aquestive Therapeutics today announced the completion, as planned, of the rolling submission of a new drug application to the U.S. FDA for its therapeutic candidate Libervant (diazepam) buccal film for the management of seizure clusters.
Libervant has received orphan drug designation from the FDA.
Libervant is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled seizures in selected, refractory patients with epilepsy on stable regimens of AEDs who require intermittent use of diazepam to control bouts of increased seizure activity.
