Benzinga | Feb 25, 2021 11:07AM EST

Aquestive Sees Libervant Application Resubmission By End Of Q2

* The FDA has provided further guidance to Aquestive Therapeutics Inc (NASDAQ: AQST) regarding the information to be included in the marketing application for Libervant to manage seizure clusters.

* This guidance FDA addresses the revised weight-based dosing regimen, modeling, and simulation data provided to the Agency in December 2020.

* The feedback offers direction on the FDA's expectations for the information and supporting analysis relating to the population pharmacokinetic model.

* The agency also guided its expectations around the nature and format of safety data included in the resubmission.

* The company plans to resubmit the marketing application around the end of the second quarter of 2021.

* Aquestive received a Complete Response Letter from the FDA in September last year citing exposure levels in certain weight groups.

* Libervant is a buccally (inside of the cheek) administered soluble film formulation of diazepam, a benzodiazepine, for rapid treatment of acute uncontrolled seizures.

* Price Action: AQST shares are 3.74% at $5.28 on the last check Thursday.