Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant® (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to Five

Core Points - The U.S. FDA has granted seven years of orphan drug exclusivity to Libervant® (diazepam) Buccal Film for treating seizure clusters in pediatric patients aged 2 to 5 [1] - Libervant is the first and only FDA-approved orally administered rescue therapy for this specific patient population [2] - The FDA's orphan designation provides financial incentives and market exclusivity benefits for drugs treating rare diseases affecting fewer than 200,000 people in the U.S. [1] Company Overview - Aquestive Therapeutics, Inc. is focused on advancing medicines through innovative science and delivery technologies, with a portfolio that includes five commercialized products [11] - The company aims to provide non-invasive treatment alternatives to existing therapies for patients with refractory epilepsy [3] - Libervant was originally granted Orphan Drug Designation on November 10, 2016, and the exclusivity extends to April 2031 [1] Product Details - Libervant is a buccal film formulation of diazepam intended for acute treatment of frequent seizure activity distinct from a patient's usual seizure pattern [3] - The product was approved for pediatric patients aged 2 to 5 in April 2024, following tentative approval for patients aged 12 and older in August 2022 [3] - The buccal route of administration is considered a significant improvement over the rectal route, enhancing ease of use for caregivers [1]