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FDA Accepts Epinephrine (Anaphylm) Sublingual Film NDA for Type 1 Allergic Reactions
With the FDA acceptance of the NDA, the agency has assigned a PDUFA target action date of January 31, 2026, and may require an Advisory Committee meeting for approval.
Aquestive Therapeutics has announced that the US Food and Drug Administration (FDA) acceptance of the Company’s New Drug Application (NDA) for epinephrine (Anaphylm) sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis.1
Announced on June 16, 2025, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. According to a release from Aquestive, the agency reiterated that it may decide to conduct an Advisory Committee meeting for the approval of epinephrine sublingual film. If approved, it would be the first and only orally delivered epinephrine option for the treatment of severe allergic reactions in the United States.1
"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," David Stukus, MD, a 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, said in a statement.1 "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."
Epinephrine sublingual film is a polymer matrix-based epinephrine prodrug product candidate. It is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact, with no water or swallowing required for administration. As described by Aquestive, the packaging 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.1
“Anaphylm represents a breakthrough in anaphylaxis treatment, if approved by FDA, being the first and only device-free, orally delivered epinephrine medicine,” said Dan Barber, president and chief executive officer of Aquestive.1 “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.”
In the Oral Allergy Syndrome challenge study of adults with allergen-induced oral physiological change, epinephrine sublingual film achieved key primary and secondary endpoints for resolving symptoms of severe allergic reactions, such as anaphylaxis. Results showed the rapid resolution of allergen-related symptoms began 2 minutes after administration, with a comparable pharmacokinetic profile after allergen exposure to a non-allergen profile.2
Aquestive Therapeutics received positive feedback from the FDA on epinephrine sublingual film for the treatment of severe allergic reactions, including anaphylaxis, in December 2024 during a pre-NDA meeting, reaffirming the Company’s plans for an NDA submission in Q1 of 2025 with no additional adult clinical trials required before application.3
Later, in April 2025, Aquestive announced positive topline results from its pediatric study for epinephrine sublingual film in patients 7-17 years of age weighing > 30 kilograms with a personal history of allergic reactions, marking the completion of its clinical program and supporting the clinical data needed for the NDA submission.4
The pediatric study was a multi-site, single treatment study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of epinephrine sublingual film. A total of 32 patients completed the study, and pharmacokinetic results were consistent with previous adult studies. Of note, epinephrine sublingual film was shown to be safe and well-tolerated with no serious adverse events reported.4
“Our clinical data demonstrates Anaphylm’s ability to rapidly deliver epinephrine absorption orally,” Barber said in a statement.1 “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.”
References
Aquestive Therapeutics. Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions. June 16, 2025. Accessed June 19, 2025. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-fda-acceptance-new-drug-0
Iapoce C. Anaphylm Sublingual Film Achieves Rapid Resolution of Allergen-Related Symptoms. HCPLive. October 24, 2024. Accessed June 19, 2025. https://www.hcplive.com/view/anaphylm-sublingual-film-achieves-rapid-resolution-of-allergen-related-symptoms
Iapoce C. Anaphylm Sublingual Film for Anaphylaxis Receives Positive FDA Feedback. HCPLive. December 2, 2024. Accessed June 19, 2025. https://www.hcplive.com/view/anaphylm-sublingual-film-for-anaphylaxis-receives-positive-fda-feedback
Derman C. Aquestive’s Anaphylm for Severe Allergic Reactions Shows Promise in Children. HCPLive. April 1, 2025. Accessed June 19, 2025. https://www.hcplive.com/view/aquestive-s-anaphylm-for-severe-allergic-reactions-shows-promise-in-children
