Core Insights - The FDA has accepted Aquestive Therapeutics' New Drug Application (NDA) for Anaphylm™, with a target action date set for January 31, 2026, potentially making it the first orally delivered epinephrine treatment for severe allergic reactions in the U.S. [1][2] Company Overview - Aquestive Therapeutics is focused on advancing innovative medicines to improve patients' lives through unique science and delivery technologies, with a portfolio that includes four commercialized products and ongoing collaborations with other pharmaceutical companies [5]. Product Details - Anaphylm™ is a polymer matrix-based sublingual film that is designed to dissolve on contact, requiring no water or swallowing for administration. It is compact, weighing less than an ounce and smaller than a credit card, making it convenient for patients to carry [3][4]. - The product aims to address significant barriers in anaphylaxis treatment, such as the fear of administration and the inconvenience of carrying bulky devices, potentially transforming care for patients at risk of severe allergic reactions [2][3]. Clinical and Regulatory Context - The FDA may conduct an Advisory Committee meeting regarding the approval of Anaphylm™, which underscores the importance of the product in the treatment landscape for anaphylaxis [1][2]. - Clinical data supports Anaphylm's ability to deliver rapid epinephrine absorption orally, which is critical for patients who may hesitate to use traditional epinephrine devices [2].