Dec. 02, 2019: Aquestive Therapeutics, Inc. announced the completion, as planned, of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its therapeutic candidate Libervant™ (diazepam) Buccal Film designed for the management of seizure clusters. Libervant has received orphan drug designation by FDA.
Aquestive Therapeutics look forward to sharing the results from the single dose crossover study at the imminent American Epilepsy Society 2019 Annual Meeting. These results will confirm the dosing algorithm and satisfy the final clinical requirement as requested by the FDA.
Libervant has a potential to be the first oral therapy approved by the FDA for managing seizure clusters in the population of 1.2 million refractory epilepsy patients and also the first diazepam based treatment method and delivering a consistent predictable dose to almost all patients. https://fda.einnews.com/pr_news/503772367/aquestive-therapeutics-completes-rolling-submission-of-new-drug-application-nda-to-u-s-food-and-drug-administration-fda-for-libervant-diazepam