FDA Approves Libervant™ Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years
Aquestive Therapeutics, Inc. has announced that 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.
- In 2023, over 55,000 prescriptions were filled for patients between the ages of 2 and 5. This was an increase of 10.8% over the previous year. Prescription writing for this indication is highly concentrated among pediatric epileptologists and pediatric neurologists.
- Libervant™ is a film formulation of diazepam administered inside the cheek. Do not give Libervant™ to your child if your child is allergic to diazepam or any of the ingredients in Libervant™ or has an eye problem called acute narrow angle glaucoma.
Source: Aquestive Therapeutics, Inc.