FDA accepts NDA for epinephrine sublingual film to treat type 1 allergic reactions | Image credit: Contemporary Pediatrics

The FDA has accepted a new drug application (NDA) for epinephrine sublingual film (Anaphylm; Aquestive Therapeutics) to treat type 1 allergic reactions, including anaphylaxis. With the acceptance of the application, the federal agency has assigned a target action date of January 31, 2026, for a decision according to a press release from Aquestive.¹

If approved, epinephrine sublingual film would be the first and only orally-delivered, device-free epinephrine option to treat severe allergic reactions in the United States, according to the company.

"Anaphylaxis is an unpredictable, severe allergic reaction that can be life-threatening within minutes. While epinephrine remains the only FDA-approved first-line treatment, too many at-risk individuals don't carry it consistently or hesitate to use it when seconds count," said David Stukus, MD, professor, Clinical Pediatrics; director, Food Allergy Treatment Center, Nationwide Children's Hospital, 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," said Stukus in a statement.

Make-up of epinephrine sublingual film

The film is a polymer matrix-based epinephrine prodrug product candidate that is comparable in size to a postage stamp and weighs less than 1 ounce, according to Aquestive. No water or swallowing is required for administration, and the film is "designed to withstand weather excursions such as exposure to rain and/or sunlight," Aquestive stated in the NDA acceptance announcement.

Recent data for epinephrine sublingual film

After initiating the NDA submission process with the FDA on March 5, 2025, Aquestive announced positive results from a pediatric study evaluating the film in pediatric patients aged 7 to 17 years on April 1, 2025.^2,3

The study, which included children weighing over 30 kilograms with a history of allergic reactions, marked the completion of the Anaphylm clinical program and supported the company’s NDA.

The multi-site, single-treatment study assessed pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Anaphylm in pediatric patients. According to the company, PK results were consistent with earlier adult studies, and Anaphylm was well-tolerated with no serious adverse events reported.

“These results demonstrate that Anaphylm maintains its consistent PK profile in pediatric patients between the ages of 7 and 17 and weighing greater than thirty kilograms,” said Daniel Barber, president and CEO of Aquestive, in the April announcement.

References:

1. Aquestive Therapeutics announces FDA acceptance of new drug application and PDUFA date for Anaphylm for the treatment of severe allergic reactions. Aquestive Therapeutics. Press release. June 16, 2025. Accessed June 17, 2025. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-fda-acceptance-new-drug

2. Aquestive Therapeutics reports fourth quarter and full year 2024 financial results and provides business update. Aquestive Therapeutics. Press release. March 5, 2025. Accessed June 17, 2025. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-reports-fourth-quarter-and-full-year-2024

3. Ebert M. Anaphylm sublingual film demonstrates positive results in pediatric patients with severe allergic reactions. Contemporary Pediatrics. April 1, 2025. Accessed June 17, 2025. https://www.contemporarypediatrics.com/view/anaphylm-sublingual-film-demonstrates-positive-results-in-pediatric-patients-with-severe-allergic-reactions