WARREN, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today provided an update on the development timeline and pathway for its oral epinephrine product candidate, Anaphylm™.

WARREN，N.J.，2023年9月20日（GLOBE NEWSWIRE）-Aquestive Therapeutics，Inc。（纳斯达克股票代码：AQST），一家制药公司，致力于推进药品，以解决患者目前的护理标准问题，并提供变革性产品以改善他们今天提供了口服肾上腺素产品候选药物过敏反应的发展时间表和途径的最新情况™.

As previously disclosed, Aquestive submitted its revised protocol for the proposed pivotal PK clinical trial to the Food and Drug Administration (FDA) in August 2023. The Company intends to commence the pivotal trial in the fourth quarter 2023, following alignment with the FDA. In addition, the Company’s current development plan continues to include a standard repeat-dose study of Anaphylm and an already-approved comparator.

如前所述，Aquestive于2023年8月向食品和药物管理局（FDA）提交了其修订的拟议关键PK临床试验方案。该公司打算在与FDA保持一致后于2023年第四季度开始关键试验。此外，公司目前的发展计划继续包括过敏反应的标准重复剂量研究和已经批准的比较。

Earlier this year, the Company disclosed repeat-dose data of Anaphylm 12mg at 25 minutes post initial dosing from Study AQ109102 including a cross-study comparison to epinephrine manual injection 0.3mg with a repeat dose at 10 minutes post initial dosing. Further information on this comparison is available in the Company’s corporate presentation located on the Investor page of the Company’s website.

今年早些时候，该公司公开了来自研究AQ109102的初始给药后25分钟的过敏性12mg的重复剂量数据，包括与初始给药后10分钟重复剂量的0.3mg肾上腺素手动注射的交叉研究比较。有关此比较的更多信息，请参阅本公司网站投资者页面上的公司报告。

“Based on our previous interactions with the FDA and our review of publicly available disclosures, we continue to anticipate starting our pivotal trial in the fourth quarter 2023,” stated Daniel Barber, Chief Executive Officer of Aquestive. “We are focused on completing the necessary work to reach our goal of filing our NDA in 2024.” Mr.

Aquestive首席执行官丹尼尔·巴伯（Daniel Barber）说：“基于我们之前与FDA的互动以及我们对公开披露的审查，我们继续期待在2023年第四季度开始我们的关键性试验。”。“我们专注于完成必要的工作，以实现2024年提交NDA的目标。”先生。

Barber continued, “We are advancing the development of Anaphylm, the first and only non-invasive, orally delivered epinephrine product candidate to demonstrate clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emerge.

理发师继续说：“我们正在推进过敏反应的发展，这是第一个也是唯一一个非侵入性的口服肾上腺素产品候选药物，用于证明emerge的临床结果与自动注射器（如EpiPen®和Auvi-Q®）相当。