Aquestive(US:AQST) Globenewswire·2025-07-15 11:00Core Viewpoint - Aquestive Therapeutics is advancing its regulatory strategy for Anaphylm™ (epinephrine) Sublingual Film, with meetings scheduled with Health Canada and the European Medicines Agency, aiming to provide a needle-free treatment option for anaphylaxis [1][2][4]. Regulatory Strategy - The company has received a meeting with Health Canada to discuss its New Drug Submission for Anaphylm™ and has submitted an initial briefing book to the EMA [1][8]. - A Marketing Authorization Application (MAA) is planned for submission to the EMA as soon as possible [1][2]. Product Overview - Anaphylm™ is an orally administered epinephrine product that addresses issues related to traditional auto-injectors, such as needle phobia and device malfunctions [3][6]. - The product is designed to be portable, weather-resistant, and easy to use, requiring no water or swallowing for administration [6]. Market Focus - The company's ex-U.S. regulatory strategy targets markets with significant unmet medical needs, with Canada and the EMA being prioritized due to their supportive regulatory environments [4][5]. - The company aims to establish Anaphylm as the new standard of care for severe allergic reactions and anaphylaxis globally [5]. Company Background - Aquestive Therapeutics has a portfolio of six FDA-approved drugs and a global presence across six continents, which enhances its ability to navigate international regulatory processes [2][7]. - The company is also developing other product candidates, including a topical gel for dermatological conditions [7].