The Food and Drug Administration (FDA) has accepted for review the New Drug Application for Libervant® (diazepam; Aquestive Therapeutics) buccal film for the management of seizure clusters.
Libervant is a buccally administered soluble film of diazepam used to treat acute uncontrolled seizures in patients with refractory epilepsy on stable regimens of antiepileptic drugs (AEDs). The application was supported by data from a phase 1/2, randomized, open-label, 2-way crossover study (NCT03953820) that compared diazepam buccal film with Diastat rectal gel in adult patients on a stable regimen of AEDs. Patients were dosed according to a weight-based regimen. Findings showed that treatment with diazepam buccal film resulted in similar systemic exposures to Diastat with significantly less variability.
“We believe that our drug candidate Libervant will, if approved by the FDA, represent a major contribution to patient care, as compared to available treatment options, and further expand patient choice as the first orally administered dosage form available to manage seizure clusters in epilepsy patients,” said Keith J. Kendall, CEO of Aquestive. A Prescription Drug User Fee Act (PDUFA) target date of September 27, 2020 has been assigned to the application.
Recently, the FDA approved 2 additional therapies for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern: Valtoco (diazepam; Neurelis) nasal spray and Nayzilam (midazolam; UCB) nasal spray.
For more information visit aquestive.com.