FDA Assigns Review Date for Libervant Film for Young Children

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target goal date for April 28, 2024, for Aquestive Therapeutics’ Libervant (diazepam) buccal (inside of the cheek) film for children between two and five years of age. If approved, it would treat intermittent, stereotypic episodes of frequent seizure activity in these patients.

About 3.4 million people with epilepsy nationwide, including 470,000 children, according to the CDC. About 0.6% of children aged 0 to 17 years of age have active epilepsy. And about 20% to 40% of patients with epilepsy are likely to have refractory epilepsy, according to UpToDate.

“When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access,” Daniel Barber, CEO of Aquestive, said in a press release.

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. It can be administered with or without food, which company executives said is important for acute use. But Libervant is not expected to be available 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. Before Valtoco’s approval, current standard of care was a rectal gel formulation of diazepam.

The FDA can issue orphan drug status when a therapy treats a disease or condition that affects fewer than 200,000 people in the United States. In addition to seven years of marketing exclusivity, the program provides tax credits and a waiver of PDUFA application fees.