Aquestive Therapeutics to Present Crossover Study Data for Libervant (diazepam) Buccal Film at 76th Annual Meeting of the American Academy of Neurology

WARREN, N.J., April 12, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today 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.

“This study underscores our ongoing dedication to enhancing the well-being of individuals battling epilepsy,” said Dan Barber, Aquestive President and Chief Executive Officer. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy between ages two to five, we believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population.”

Poster Title: Crossover Study Evaluating the Effect of Seizures on the Absorption of Diazepam From a Buccal Film Formulation in Children With Epilepsy
Poster Session 9: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Mechanisms, Pharmacokinetics, and Urgent Applications
Presentation Time: Wednesday, April 17, from 8:00 AM - 9:00 AM.
Lead Author: Gary Slatko, MD, Steve Wargacki, PhD, Michael A. Rogawski, MD, PhD

The abstract is available online at American Academy of Neurology Annual Meeting, as well on the Company’s website at the following Link.

About Libervant
Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. 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. Diastat (diazepam) 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. The NDA for Libervant was assigned a PDUFA target action date of April 28, 2024.