Business
Aquestive Therapeutics Reports Third Quarter 2021 Financial Results, Provides Business Update and Improves Full Year Guidance
Libervant™ (diazepam) Buccal Film continues to progress through the FDA review process in advance of PDUFA goal date of December 23, 2021AQST-109 top line
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Libervant™ (diazepam) Buccal Film continues to progress through the FDA review process in advance of PDUFA goal date of December 23, 2021AQST-109 top line Phase 1 trial demonstrates clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of allergic reactions, including anaphylaxisImproves full year revenue and earnings guidanceHosts conference call at 8:00 a.m. ET on November 3, 2021 WARREN, N.J., Nov. 02, 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, today reported financial results for the third quarter ended September 30, 2021 and provided an update on recent developments in its business. “We continue to interact with the FDA regarding the NDA submission for Libervant, including responding to several information requests to date, having a recent inspection of our post-marketing adverse event capabilities, regarding changes in language relating to our packaging, approval of the product trade name and an update to the patent information included in the resubmission. We are continuing to prepare for commercialization with payer and sales force planning underway,” said Keith Kendall, Chief Executive Officer of Aquestive. “We recently demonstrated clinical results comparable to the autoinjectors in the recently completed Phase 1 trial for AQST-109, potentially the first orally administered epinephrine product for the emergency treatment of allergic reactions, including anaphylaxis. Before year end, we anticipate receiving written feedback from the FDA following our pre-IND meeting request and plan to commence an adaptive design crossover study that will determine the final formulation and dose strength leading to our pivotal PK study in 2022.” Libervant™Libervant™ is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled seizures in selected, refractory patients with epilepsy on stable regimens of AEDs who require intermittent use of diazepam to control bouts of increased seizure activity. The Company believes that Libervant, if approved by the U.S. Food and Drug Administration (FDA) for U.S. market access, ...