Sublingual Epinephrine Film Well Tolerated in Children, With David Golden, MD

At the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, David Golden, MD, clinical associate professor of medicine at Johns Hopkins University School of Medicine, shared insights with HCPLive on the safety and potential impact of AQST-109 (Anaphylm), a sublingual epinephrine film recently evaluated in a pediatric phase 1 trial.

The open-label, single-treatment study enrolled 32 children aged 7 to 17 years with a history of allergic reactions and high risk for anaphylaxis. According to Golden, the treatment demonstrated a favorable safety and tolerability profile consistent with adult data and traditional injectable epinephrine.

Adverse events were frequently observed but aligned with the expected pharmacologic effects of the sublingual formulation. Because the film is administered under the tongue, local reactions such as mild tingling and irritation, or redness were common. These effects were generally minor, resolved quickly without intervention, and did not discourage participants from future use.

Systemic side effects, including temporary shakiness, headache, and increased heart rate, were consistent with the known response to epinephrine. These transient reactions are considered pharmacodynamic markers of drug activity rather than safety concerns.

“If nobody had those side effects, the drug probably wouldn’t be working,” Golden said.

Golden emphasized that, unlike injectable epinephrine, sublingual delivery avoids needle-related pain and fear, which are among the biggest barriers to timely use. While injectables may cause site pain or bruising, sublingual administration mainly produces local oral effects, offering a different but predictable safety profile. According to Golden, research is underway to develop an appropriate sublingual dose for children weighing under 30 kilograms, which could further expand access to fast-acting, easy-to-use epinephrine therapy for pediatric anaphylaxis.

“Epinephrine is not a dangerous drug,” he said. “It may make your heart race, it may make you shaky. That just shows that it's working. Can it raise the blood pressure and heart rate in an elderly person who has heart problems? Yes. But if that person is [experiencing] anaphylaxis, that's way more dangerous than giving them the epinephrine. There's actually no contraindication to giving epinephrine to someone in anaphylaxis, none at all, even if they just had heart surgery yesterday.”

A relevant disclosure for Golden includes Genentech USA, Inc and Phadia US, Inc.

References

Greenhawt M, Anagnostou A, Christensen S, et al. Phase 1 Evaluation of Sublingual Film: Pharmacokinetics/Pharmacodynamics Safety Tolerability in at Risk Pediatric Patients. Presented at ACAAI 2025 in Orlando, Florida on Saturday, November 8, 2025