Tuesday, September 12, 2023
Aquestive Therapeutics, Inc. (NASDAQ: AQST) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film. The NDA pertains to the use of Libervant in pediatric patients between the ages of two and five who experience intermittent, stereotypic episodes of frequent seizure activity, such as seizure clusters or acute repetitive seizures. The FDA has provided a PDUFA goal date for the review of this NDA, scheduled for April 28, 2024.
Currently, Diastat® (diazepam) Rectal Gel is the sole available treatment for this specific patient population and indication. It's noteworthy that Aquestive had previously received tentative approval for Libervant for the treatment of similar conditions in patients aged 12 and older back in August 2022. However, due to orphan drug market exclusivity regulations, Libervant is restricted from entering the market for patients aged 12 and older until January 2027.
Libervant is an innovative buccal film formulation of diazepam, intended for the acute treatment of seizure clusters and acute repetitive seizures that differ from a patient's usual seizure pattern. This formulation serves as a valuable alternative to the currently available device-based products, including rectal gel and nasal spray, for patients suffering from refractory epilepsy.
If granted approval by the FDA, Libervant has the potential to offer a critical treatment option for pediatric patients between the ages of two and five who experience these types of seizures. It would provide a more convenient and potentially safer alternative to existing treatments, addressing a significant unmet medical need in this patient population.