The FDA accepted Aquestive Therapeutics’ New Drug Application (NDA) for Libervant (diazepam) Buccal Film for seizure clusters. It has a target action date of September 27, 2020.
Libervant is a formulation of diazepam on a soluble film that is administered on the inside of the cheek. It is intended for fast treatment of acute uncontrolled seizures in refractory patients with epilepsy on stable anti-epileptic drugs (AEDs). If approved, it will be the first oral diazepam-based therapy approved for seizure clusters. The FDA granted it Orphan Drug designation in November 2016.
“The FDA filing acceptance for Libervant is an important milestone in our mission to provide epilepsy patients with a broader array of treatment options, that represent major contributions to patient care,” said Keith J. Kendall, Aquestive’s chief executive officer.