Aquestive Therapeutics Comments on FDA Approval of Non-Injectable Epinephrine for Anaphylaxis and Updates Anaphylm™ NDA Timing

Aquestive Therapeutics, Inc., a pharmaceutical company dedicated to improving patient outcomes through innovative delivery technologies, has lauded the FDA's approval of the first non-injection-based epinephrine device for treating severe allergic reactions, including anaphylaxis. Aquestive’s Chief Executive Officer, Daniel Barber, expressed excitement about this development, highlighting that epinephrine, traditionally administered via needle since its initial FDA approval in 1939, now has a less invasive alternative. Barber emphasized that non-injection-based forms could improve patient adherence and ease of use, making it more likely for patients to carry and use the medication promptly when needed.

Aquestive is advancing its own non-injection-based epinephrine product, Anaphylm™ (epinephrine) Sublingual Film, which is in the late stages of development. Anaphylm has the potential to become the first oral epinephrine product for treating severe allergic reactions, including anaphylaxis. The company's supportive study for Anaphylm, focusing on oral allergy syndrome (OAS), is expected to conclude by late third quarter or early fourth quarter of 2024. Aquestive plans to file a New Drug Application (NDA) with the FDA in the first quarter of 2025, aiming for a full product launch by late 2025 or early 2026, pending FDA approval.

Sung Poblete, PhD, RN, CEO of Food Allergy Research & Education (FARE), noted the critical role that needle-free epinephrine devices play in reducing injection hesitancy, which can delay life-saving treatment. Poblete expressed optimism about the FDA's approval of the first alternative treatment for anaphylaxis, underscoring the community’s eagerness for more options and better access to care.

John Oppenheimer, MD, Director of Clinical Research at Pulmonary and Allergy Associates, and Clinical Professor of Medicine at UMDNJ-Rutgers, also welcomed the FDA's approval of the non-needle form of epinephrine. He emphasized the importance of having easily accessible and user-friendly epinephrine options to ensure timely administration during severe allergic reactions without the barrier of needle fear.

Anaphylm is a polymer matrix-based epinephrine prodrug candidate administered as a sublingual film. Comparable in size to a postage stamp and weighing less than an ounce, the film begins to dissolve upon contact, requiring no water or swallowing. The packaging is designed to be compact and resilient, fitting easily into a pocket and withstanding various weather conditions. The tradename “Anaphylm” has been conditionally approved by the FDA, pending final approval upon the product’s FDA approval.

Aquestive’s broader mission is to develop orally administered products that provide novel alternatives to traditional, invasive therapies. The company currently has five commercialized products marketed by licensees worldwide and serves as the exclusive manufacturer of these products. Aquestive collaborates with other pharmaceutical companies to bring new molecules to market using their proprietary PharmFilm® technology, demonstrating proven drug development and commercialization capabilities.

In addition to Anaphylm, Aquestive is also developing an earlier-stage epinephrine prodrug topical gel for various dermatological conditions. The company remains focused on solving patients’ problems with current standards of care by delivering transformative products that improve lives through innovative science and delivery technologies.