FDA accepts NDA for Libervant Buccal Film for the treatment of seizure clusters. -Aquestive Therapeutics.

Aquestive Therapeutics, Inc. announced that, as anticipated, the FDA accepted the Company’s New Drug Application (NDA) for Libervant (diazepam) Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020. If approved by the FDA, Libervant will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 million refractory epilepsy patients. Libervant was designated by the FDA as an orphan drug in November 2016. The NDA submission was supported by data from Aquestive’s single dose crossover study that was recently featured as a late breaker session at the American Epilepsy Society (AES) 2019 Annual Meeting and expanded upon by key opin leaders at its investor and analyst forum held on December 9, 2019. This study demonstrated that Libervant provided similar systemic diazepam exposures to the reference drug and exhibited significantly less variability. The study supports the use of Libervant as an easily-administered treatment for patients with epilepsy experiencing seizure emergencies.