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Aquestive Aquestive Therapeutics Reports Third Quarter 2021 Financial Results , Provides Business Update and Improves Full Year Guidance November 2 , 2021 • LibervantTM ( diazepam ) Buccal Film continues to progress through the FDA review process in advance of PDUFA goal date of December 23 , 2021 • AQST - 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 anaphylaxis Improves full year revenue and earnings guidance • Hosts 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 , will enable a larger share of patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non - invasive and innovative treatment form for epileptic seizures . Aquestive is developing Libervant as an alternative to more invasive , inconvenient , and difficult to administer device driven products , including a rectal gel and nasal spray , for patients with refractory epilepsy . A large portion of the patient population still does not access either one of these existing products and remains underserved with regard to having an important medication where they need it , when they need it and in a form they prefer . Aquestive continues to actively engage with the FDA regarding its accepted New Drug Application ( NDA ) for Libervant ahead of the Prescription Drug User Fee Act ( PDUFA ) target goal date of December 23 , 2021. Aquestive has again spoken with and provided additional information to the FDA Office of Orphan Products Development ( OOPD ) that the Company believes provides a clear position of clinical superiority as a major contribution to patient care as compared to the device driven rectal gel and nasal spray alternatives . Epinephrine Aquestive continues to advance its development of product candidate AQST - 109 ( epinephrine prodrug sublingual film ) for the emergency treatment of severe allergic reactions , including anaphylaxis , utilizing Aquestive's PharmFilmⓇ technologies . The Company reported positive topline data from its first - in - human Phase 1 pharmacokinetic ( PK ) trial for AQST - 109 . Findings from this study support AQST - 109's potential as the first orally administered and transformative epinephrine - based product for the treatment of allergic reactions including anaphylaxis with safety , tolerability , PK and pharmacodynamics ( PD ) measures comparable to those of the standard of care autoinjectors , such as EpiPen® and Auvi - Q® . These products require patients or caregivers to inject epinephrine into their thighs during an emergency allergic reaction . However , AQST - 109 would , if approved by the FDA , allow a patient to simply place a dissolvable strip , approximately the size and weight of a postage stamp , under the tongue , again providing an appropriate medication where it is needed , when it is needed and in a form preferred by patients . Aquestive has submitted its request for a pre - Investigational New Drug ( IND ) meeting with the FDA and anticipates receiving a written response from the FDA before year end 2021. Aquestive is on track to conduct a crossover study using an adaptive design for AQST - 109 beginning in the fourth quarter 2021. This study will determine the final formulation and dose for AQST - 109 and allow the Company to move forward to the manufacture of registration batches and a pivotal PK study in 2022 . SympazanⓇ The Company's proprietary product Sympazan ® ( clobazam ) , an oral film for the treatment of seizures associated with Lennox - Gastaut syndrome , continued to grow in shipment volumes to the prescriber base for the third quarter 2021. Sympazan has grown quarterly over the past eleven sequential quarters since its launch . Third Quarter 2021 Financials Total revenues were $ 13.3 million in the third quarter 2021 , compared to $ 8.3 million in the third quarter 2020. For the third quarter 2021 compared to the prior year period , the Company saw an 18 % increase in Sympazan net revenue and a 77 % increase in manufacture and supply revenue .