The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Libervant™ (diazepam 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). In February 2020, the NDA submission included data from a randomized, open-label, 2-way crossover, phase 1/2 study that compared diazepam buccal film with Diastat rectal gel in adult patients on a stable regimen of AEDs. Findings from the study showed that treatment with diazepam buccal film resulted in similar systemic exposures to Diastat with significantly less variability.
In September 2020, the FDA issued a Complete Response Letter to Aquestive Therapeutics stating that the study showed a lower drug exposure level than desired in certain weight groups, and citing a “small number of protocol deviations in blood draws in 1 of the studies in the NDA.” To address these issues, the Company provided the FDA with additional statistical modeling and supporting analyses of the existing clinical data.
A Prescription Drug User Fee Act (PDUFA) target date of December 23, 2021 has been set for the application.
“We are pleased with the FDA’s decision to accept for review the Libervant NDA,” stated Keith Kendall, CEO of Aquestive. “We are preparing for the commercial launch of Libervant, if approved for US market access, in the first half of 2022 and remain committed to fill this unmet need and improve the quality of life for patients suffering from this disease with this first of its kind treatment option.”
Aquestive Therapeutics announces FDA acceptance of New Drug Application (NDA) resubmission for Libervant™ (diazepam) buccal film. News release. Aquestive Therapeutics, Inc. Accessed July 19, 2021. https://www.globenewswire.com/news-release/2021/07/19/2264932/0/en/Aquestive-Therapeutics-Announces-FDA-Acceptance-of-New-Drug-Application-NDA-Resubmission-for-Libervant-diazepam-Buccal-Film.html.