FDA Approves Libervant Film for Epilepsy in Young Children

The FDA has approved Aquestive Therapeutics’ Libervant (diazepam) buccal (inside of the cheek) film for children between 2 and 5 years of age who have refractory epilepsy. It is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity — including seizure clusters and acute repetitive seizures — that are distinct from a patient’s usual seizure pattern.

About 3.4 million people with epilepsy nationwide, including 470,000 children, according to the CDC. More than 90% of filled prescriptions in 2023 for this patient population were for diazepam rectal gel, Aquestive officials said.

Libervant is a benzodiazepine and is the first FDA approved orally-administered rescue product for the treatment of seizure clusters. Dosage of Libervant is based on weight and is available in 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg doses. Company officials said in an earnings call the wholesale acquisition cost is in line with the diazepam rectal gel. Diastat (diazepan) rectal gel, for example, has a list price of $379 for one kit of the 10 mg dose, according to Drugs.com.

Company official indicated they are currently able to accept and fill non-Medicaid prescriptions. They expect to expand distribution capabilities over the coming weeks and months.

Michael Rogawski, M.D., Ph.D.

“The film is placed onto the buccal mucosa inside the cheek where it adheres firmly and dissolves quickly, delivering a consistent dose of diazepam. Studies show that the film is easy to administer and performs reliably in children as young as 2 years of age. Libervant is packaged in a compact foil pouch that is convenient to carry so that the treatment can be available wherever these children may be,” Michael Rogawski, M.D., Ph.D., distinguished professor of neurology and pharmacology, University of California, Davis, said in a news release.

Company executives in the investor call said the company is pursuing approval for children 6 years and up. In August 2022, the FDA issued a tentative approval of Libervant to treat intermittent, stereotypic episodes of frequent seizure activity in those 12 years of age or older.

But Libervant is not expected to be available for this population until January 2027 because of existing orphan drug market exclusivity held by Valtoco (diazepam) nasal spray. Valtoco was approved by the FDA in January 2020 and its marketing exclusivity ends Jan. 10, 2027.