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Aquestive Therapeutics Receives U.S. FDA Approval and Market Access for Libervant™ (diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 and Provides Update on Anaphylm™ (epinephrine) Sublingual Film
AquestiveAquestive(US:AQST) Newsfilter·2024-04-29 11:00

Core Insights - The FDA has approved Libervant™ (diazepam) Buccal Film for the treatment of seizure clusters in patients aged 2 to 5, marking it as the first and only orally administered rescue product for this indication [1][2][5] - Libervant is now available in multiple dosages (5mg, 7.5mg, 10mg, 12.5mg, and 15mg) for the target age group [1] - The company has achieved a total of four FDA approvals since 2018, demonstrating a strong track record in regulatory success [1][2] - The Anaphylm™ (epinephrine) Sublingual Film program is on track, with a New Drug Application (NDA) submission expected by the end of 2024 [3] Product Details - Libervant is designed for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity distinct from a patient's usual seizure pattern [1][5] - The buccal film formulation adheres to the buccal mucosa and dissolves quickly, providing a consistent dose of diazepam [2] - In 2023, over 55,000 prescriptions were filled for patients aged 2 to 5, reflecting a 10.8% increase from the previous year [2] Company Overview - Aquestive Therapeutics, Inc. focuses on advancing medicines through innovative science and delivery technologies, with a pipeline aimed at treating central nervous system diseases and severe allergic reactions [13] - The company has five commercialized products marketed globally and collaborates with other pharmaceutical companies to develop new molecules [13] Upcoming Events - The company will host a conference call for investors on April 29, 2024, at 8:00 a.m. ET to discuss the FDA approval and other updates [4]