Benzinga | Jun 24, 2021 08:13AM EDT

Aquestive Therapeutics Reports Resubmission Of New Drug Application For Libervant Buccal Film

* Anticipates FDA PDUFA goal date in late 2021

* If approved by the FDA for US market access, Libervant would be the first orally delivered diazepam product for the management of seizure clusters

WARREN, N.J., June 24, 2021 (GLOBE NEWSWIRE) -- 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 the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Libervant(tm) (diazepam) Buccal Film for the management of seizure clusters in response to the September 25, 2020 Complete Response Letter (CRL) from the FDA. The submission included additional statistical modeling and supporting analyses of the existing clinical data based upon the guidance received from the Agency.

"As we have committed in previous statements regarding the filing of our NDA for Libervant, yesterday we resubmitted the NDA. The resubmission for Libervant marks a significant milestone for Aquestive. We believe that the resubmission addresses all of the issues raised in the CRL based upon the guidance we received from the FDA," remarked Keith Kendall, Chief Executive Officer of Aquestive. "We look forward to continuing our dialogue with the FDA during the review period as we remain focused on bringing our non-invasive and innovative product to the underserved population of patients with refractory epilepsy."

Aquestive received a CRL from the FDA in September 2020, completed a Type A meeting with the FDA in November 2020 and received further guidance from the FDA in February 2021. The Company anticipates a six-month review process and expects to receive a PDUFA goal date in late 2021.