Aquestive Therapeutics, Inc. (NASDAQ: AQST) has announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding its planned New Drug Application (NDA) submission for Anaphylm™ (epinephrine) sublingual film. The company has stated that it has received affirmation of its NDA first quarter 2025 submission guidance and has confirmed that no additional adult clinical trials are necessary prior to the NDA submission.
The company has commenced a pediatric trial in the U.S. and Canada and believes it has a clear path to an NDA submission in the first quarter of 2025. Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis, if approved by the FDA.
The estimated 33 million Americans with food allergies currently only have the option of carrying epinephrine medical devices. Aquestive's engagement with the allergy community has informed them that bringing the first and only orally delivered epinephrine product for anaphylaxis to market can potentially be transformative for patients.
In response to the company's planned NDA content and format for the submission, planned safety evaluation, and planned pediatric trial, the FDA has agreed with the company's proposals. The FDA has also provided further guidance on additional data views to be included in the planned NDA submission and emphasized their focus on pharmacokinetic sustainability for a single dose. The FDA has also requested minor modifications to the company's pediatric trial protocol.
Anaphylm™ (epinephrine) sublingual film is a polymer matrix-based epinephrine prodrug product candidate that is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight.
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. The company is developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by the company and its licensees in the U.S. and around the world and is the exclusive manufacturer of these licensed products. The company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel for various possible dermatology conditions. As a result of these announcements, the company's shares have moved 2.7% on the market, and are now trading at a price of $5.22. Check out the company's full 8-K submission here.
