Libervant FDA Approval History
Last updated by Judith Stewart, BPharm on May 20, 2024.
FDA Approved: Yes (First approved April 26, 2024)
Brand name: Libervant
Generic name: diazepam
Dosage form: Buccal Film
Company: Aquestive Therapeutics, Inc.
Treatment for: Seizure Clusters
Libervant (diazepam) is a buccal film formulation of the benzodiazepine diazepam used to treat children aged 2 to 5 years with seizure clusters.
- Seizure clusters or acute repetitive seizures are intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern.
- Diazepam was first approved in tablet form under the brand name Valium for the treatment of anxiety disorders in 1963. Diazepam was later approved for the treatment of seizure clusters in a rectal gel formulation (Diastat, Diastat AcuDial) in 1997 and a nasal spray formulation (Valtoco) in 2020.
- Libervant is a buccal film formulation that is placed onto the buccal mucosa inside the cheek where it adheres firmly and dissolves quickly to deliver a consistent dose of diazepam.
- Libervant is administered buccally as a single dose dependent on the patient's weight. A second dose may be administered at least 4 hours after the first dose if required. No more than two doses of Libervant should be used to treat a single episode. Libervant should not be used to treat more than one episode every five days, or more than five episodes per month.
- Libervant comes with a Boxed Warning for risks from concomitant use with opioids; abuse, misuse, and addiction; and dependence and withdrawal reactions. Warnings and precautions associated with Libervant include central nervous system depression, suicidal behavior and ideation, and glaucoma.
- Common adverse reactions include somnolence and headache.
Development timeline for Libervant
Further information
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