FDA Accepts NDA for Anaphylm™, a Sublingual Epinephrine Film for Treatment of Severe Allergic Reactions

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Aquestive Therapeutics announced that the US FDA has accepted its New Drug Application (NDA) for Anaphylm™, a sublingual film formulation of epinephrine for the treatment of type 1 allergic reactions, including anaphylaxis. The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026.

If approved, Anaphylm™ would become the first and only orally delivered epinephrine product available in the US, representing a potential breakthrough in the management of anaphylaxis in both pediatric and adult populations.

"This potential drug product addresses the two biggest barriers we hear from patients – fear of administration and the inconvenience of carrying bulky devices."

Anaphylaxis is a rapid-onset, potentially fatal allergic reaction requiring prompt intramuscular administration of epinephrine. While autoinjectors remain the standard of care, barriers to consistent use persist, including needle aversion and the inconvenience of carrying bulky devices.

“Anaphylm represents a breakthrough in anaphylaxis treatment, if approved by FDA, being the first and only device-free, orally delivered epinephrine medicine,” Dan Barber, President and Chief Executive Officer of Aquestive, said in a press release.

Anaphylm is designed as a small, lightweight polymer matrix-based sublingual film that dissolves upon contact with the oral mucosa, without the need for water or swallowing. According to the company, the film is thinner than a credit card, weather resistant, and can be discreetly stored in a pocket, phone case, or wallet.

Clinical data supporting the NDA submission demonstrated Anaphylm’s ability to rapidly deliver therapeutic epinephrine levels, with pharmacokinetic profiles meeting FDA criteria for emergency use.

Physicians and researchers have expressed optimism that a device-free, orally administered epinephrine product could significantly reduce treatment hesitancy among at-risk individuals.

"The reality is stark: epinephrine can only save lives if people have it available and feel confident using it immediately," David Stukus, MD, director, Food Allergy Treatment Center, Nationwide Children’s Hospital, said in the press release.
"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."

The FDA has granted Anaphylm conditional approval for its trade name and will issue final approval upon product approval. Aquestive also has a topical epinephrine prodrug (AQST-108) in early-stage development for dermatologic indications.

The FDA has also indicated that it may conduct an Advisory Committee meeting to review Anaphylm™ as part of the approval process. If granted approval, Anaphylm™ could be available to patients as early as mid-2026, pending regulatory decisions.

Source: Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions. News release. Aquestive Therapeutics. July 16, 2025. Accessed July 17, 2025. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-fda-acceptance-new-drug-0