On April 29, 2024 Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced the FDA has approved Libervant™ (diazepam) Buccal Film 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 in patients with epilepsy between 2 to 5 years of age. According to the news release, the film is placed onto the buccal mucosa inside the cheek where it adheres firmly and dissolves quickly, delivering a consistent dose of diazepam. (1)
On March 28 2023, Aquestive Therapeutics, Inc. announced it expanded its exclusive license and supply agreement with Atnahs Pharma UK Limited (“Pharmanovia”), a global pharmaceutical company that revitalizes, extends and expands the lifecycle of established medicines, for Libervant™ (diazepam) Buccal Film to cover the rest of the world, excluding the United States, Canada, and China. The original licensing agreement with Pharmanovia announced in September 2022 covered the European Union, United Kingdom, Sweden, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA).
Libervant™ has several favorable characteristics and overcomes many of the disadvantages of other nonparenteral dosage forms used for acute seizure treatments. The thin film, which is less than the size of a postage stamp, is affixed to the buccal mucosa inside the cheek. Placement can be either by the patient or by a caregiver. Diazepam is absorbed transbucally and is also swallowed, so that a portion of the dose is transported to the stomach and absorbed by the small intestine. The polymer hydroxypropyl methylcellulose is used to hold diazepam and excipients in a uniform distribution throughout the film. Because of the uniform distribution, the dose can easily be adjusted by cutting the film. The film has a mucoadhesive surface so that it adheres to the buccal mucosa. It begins to dissolve immediately on application to the mucosa releasing diazepam. In studies with fasted healthy male volunteers, DBF doses of 5 mg to 15 mg exhibited rapid absorption and linear dose-proportional pharmacokinetics.
REFERENCES
(1) 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, Globe Newswire, Aquestive Therapeutics, Inc., Mon, Apr 29, 2024, 4:00 AM PDT.
(2) Aquestive Therapeutics Expands License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to Additional Global Markets Globe Newswire, Aquestive Therapeutics, Inc., Wed, Mar 29, 2023
(3) Michael A. Rogawski et al, Diazepam buccal film for the treatment of acute seizures, Epilepsy and Behavior, 101(2019) 106537.
