Aquestive Therapeutics Inc. (AQST) Reaffirms Near-Term NDA Resubmission for Libervant (diazepam) Buccal Film Following FDA Feedback

February 25, 2021 7:34 AM EST

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Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that the Food and Drug Administration (FDA) has provided further guidance to Aquestive regarding the information to be included in the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The further guidance from the FDA addresses the revised weight-based dosing regimen, modeling and simulations data that Aquestive provided to the Agency in December 2020.

“We have a clear path to resubmitting our NDA for Libervant and expect to do so around the end of the second quarter of 2021. The Agency provided additional guidance and clarity regarding information and supporting analysis that should be included in our resubmission,” said Keith Kendall, President and Chief Executive Officer of Aquestive. “We believe our focus on engaging in multiple communications with the FDA prior to resubmitting our application will ultimately result in a collaborative review process and we look forward to continuing our interactions with the FDA.”

The FDA’s written feedback provided direction on the FDA’s expectations for the information and supporting analysis relating to the population pharmacokinetic model, which the Company will be working to provide in a form acceptable to the FDA. Aquestive is aligned with the FDA’s expectations and will include the requested information in its upcoming resubmission of the NDA for Libervant. In addition, the FDA provided guidance on its expectations around the nature and format of safety data that should be included in the resubmission.

Aquestive received a Complete Response Letter (CRL) from the FDA on September 25, 2020 and subsequently completed a Type A meeting with the FDA in November of 2020. Based on the FDA’s feedback at the Type A meeting, as well as this further guidance from the Agency, Aquestive continues to believe that no further clinical studies are necessary for the resubmission of the NDA for Libervant. Once resubmitted, Aquestive anticipates a six month review process.



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