Aquestive Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for Anaphylm™, an orally delivered epinephrine film for treating severe allergic reactions, including anaphylaxis. The FDA has set a target action date of January 31, 2026, for its decision and may hold an Advisory Committee meeting.
Anaphylm is a thin film, comparable in size to a postage stamp, weighing less than an ounce, that begins to dissolve upon contact. No water or swallowing is necessary for administration, and the product is designed to endure weather conditions, including exposure to rain and sunlight.
If approved, Anaphylm would be the first and only orally administered epinephrine option available in the United States.
Said Dan Barber, CEO of Aquestive:
We designed Anaphylm to fit seamlessly into the patient’s daily life. It’s thinner than a credit card and requires no special storage, so patients can keep it in their phone case, wallet, or pocket – Anaphylm can go everywhere you go, without the bulk of even the smallest FDA-approved device for this patient population.
Our clinical data demonstrates Anaphylm’s ability to rapidly deliver epinephrine absorption orally. With the FDA’s acceptance of our NDA, we’re one step closer to getting this life-saving innovation in the hands of the patients and caregivers who need it most.
Said Dr David Stukus, MD, Professor of Clinical Pediatrics and Director of the Food Allergy Treatment Center at Nationwide Children’s Hospital and The Ohio State University College of Medicine:
The reality is stark: epinephrine can only save lives if people have it available and feel confident using it immediately. This potential drug product addresses the two biggest barriers we hear from patients – fear of administration and the inconvenience of carrying bulky devices. An oral, no-needle approach could be transformative for anaphylaxis care.
