Aquestive Therapeutics Hit with CRL for Libervant for Management of Seizure Clusters

The FDA has issued Aquestive Therapeutics a complete response letter (CRL) for its Libervant (diazepam buccal film) for the management of seizure clusters.

The CRL noted that one of the studies submitted with the company’s new drug application (NDA) concluded that some weight groups showed an inadequate drug exposure level. The company said it plans to submit additional information showing that dose adjustments will provide the required exposure levels.

Aquestive said it plans to resubmit the NDA before the end of the year and still expects that the drug will be approved in the first half of 2021.