Benzinga | Dec 21, 2021 05:27AM EST

Aquestive Therapeutics Announced it Received Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company's NDA for Libervant Buccal Film

Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet needs and solve therapeutic problems, announced today that, regarding the review of the New Drug Application (NDA) for Libervant(tm) (diazepam) Buccal Film for the treatment of breakthrough seizures and seizure clusters, the U.S. Food & Drug Administration (FDA) sent the following notice to the Company;

"Please refer to your NDA 212641 Libervant resubmission dated June 23, 2021.

The purpose of this e-mail is to notify you that the Agency is still considering the regulatory issues related to the approvability of Libervant, and will not be ready to take an action by December 23, 2021. No additional information is needed from you at this time. We are currently unable to provide an estimate of the timing of an expected action; however, we will provide any updates we can as they are available."

"We are surprised to receive this notification from the FDA. We accepted all of the Agency's label edits for Libervant last week and, as the Agency stated in its notice today, there is no additional information needed from the Company at this time. Following the labeling discussions, we believe the package we submitted satisfies all of CDER's requests," said Keith Kendall, Chief Executive Officer of Aquestive. "We are currently reaching out to the FDA to seek further clarity. We remain fully committed to working closely with the FDA for the duration of its review of our NDA. We continue to believe that Libervant provides a major contribution to patient care and has the potential to transform the lives of refractory epilepsy patients seeking a non-invasive and innovative product for the management of seizure clusters."

In July 2021, the FDA accepted the NDA for Libervant and assigned a Prescription Drug User Fee Act ("PDUFA") target goal date of December 23, 2021.

The Company continues to advance AQST-109 as it began the EPIPHAST study, the results of which are expected to be available in the first half of 2022.