Aquestive Therapeutics, Inc. announced a poster presentation highlighting the crossover study for the Company's product candidate, Libervant?? (diazepam) Buccal Film for treatment of children with epilepsy aged two to five, will be presented at the 76th Annual Meeting of the American Academy of Neurology (AAN) in Denver from April 13 to 18, offering both in-person attendance and live online participation in a hybrid format. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products.

The U.S. Food and Drug Administration (FDA) has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The FDA accepted Aquestive's New Drug Application (NDA) for Libervant (diazepam) BuccAL Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age in September 2023. rectal Gel is the only FDA approved treatment currently available to this pediatric patient population for this indication.

Based on the latest information available to the Company, the review of the Libervant NDA for pediatric patients aged two to five remains on track and there are currently no outstanding information requests from the FDA. Such risks and uncertainties include, but are not limited to, risks that the FDA will not approve Libervant for U.S. market access by overcoming the seven year orphan drug market exclusivity of an FDA approved nasal spray product of another company in effect until January 2027; risk of delays in or the failure to receive FDA approval of the NDA for these epilepsy patients between two and five years.