Aquestive CRL sends shares plummeting

28 September 2020

US drugmaker Aquestive Therapeutics (Nasdaq: AQST) has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant (diazepam) Buccal Film for management of seizure clusters.

In the CRL, the FDA cited that, in a study submitted by Aquestive with the NDA, certain weight groups showed a lower drug exposure level than desired.

Aquestive intends to provide to the FDA additional information on PK modeling to demonstrate that dose adjustments will obtain the desired exposure levels. There were no other safety, clinical pharmacology/biopharmaceutics or CMC issues identified in the CRL.

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