Libervant Buccal Film Approved for Seizure Clusters in Patients 2 to 5 Years Old

The Food and Drug Administration (FDA) has approved Libervant^™ (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 to 5 years of age.

The approval was based on safety and efficacy data from clinical trials evaluating diazepam rectal gel, as well as adult bioavailability studies comparing Libervant with diazepam rectal gel, adult and pediatric pharmacokinetic data, and an open-label safety study of Libervant. Pharmacokinetic data indicate that in pediatric patients 2 to 5 years of age, administration of the buccal film is expected to provide adequate therapeutic exposures under both fed and fasted states.

Libervant is supplied as a buccal film in 5mg, 7.5mg. 10mg, 12.5mg, and 15mg dosage strengths. The recommended dose is dependent on the patient’s weight. The buccal film is applied to the inside of the mouth on top of the surface of the cheek. 

As Libervant contains diazepam, a benzodiazepine, the prescribing information includes Boxed Warnings regarding the risks of concomitant use with opioids, abuse, misuse, addiction, dependence, and withdrawal reactions. The most common adverse reactions reported in patients 2 to 5 years of age were somnolence and headache.

“We are thrilled to have received FDA approval for Libervant in patients between the ages of 2 and 5,” said Daniel Barber, CEO  of Aquestive. “Patients have been waiting years for Libervant, the first and only FDA approved orally-administered rescue product for the treatment of seizure clusters.”

According to the Company, distribution of the product has already begun and will be expanded in the coming weeks and months.