Sublingual Epinephrine Film Rapidly Works in Children, With David Golden, MD

A recent phase 1 study found that AQST-109 (Anaphylm), a sublingual epinephrine film, rapidly achieves therapeutic levels in children, with effects seen within 2 minutes.

“If we talk about a level of 100 picograms as being the level where it starts to work, it achieves that within 5 to 8 minutes,” David Golden, MD, clinical associate professor of medicine at Johns Hopkins University School of Medicine, told HCPLive during an on-site interview at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida. “It actually achieves the highest concentration within 10 minutes, C max. But the important thing here is in the pharmacodynamics, epinephrine starts to work long before it reaches any really high levels in the plasma.”

He added that heart rate and blood pressure are considerably elevated at 2 minutes, suggesting that sublingual epinephrine film begins working in under 2 minutes.

Golden presented the phase 1 data on the pharmacokinetics and pharmodynamics of sublingual epinephrine film in the pediatric population during ACAAI 2025. When HCPLive sat down with Golden, he discussed these findings and how the sublingual film compares to other needle-free options, including the relatively new intranasal epinephrine spray, Neffy.

The open-label, single-treatment, multi-site trial enrolled 32 children aged 7 to 17 years (mean age: 13 years; 20% male, weighing ≥ 30 kilograms (median weight: 47.15 kg), with the goal of “bridging” pediatric pharmacokinetics and pharmacodynamics to adult data. All participants had a history of allergic reactions and were at high risk for serious allergic reactions. The study included a post-treatment follow-up on day 2.

The primary endpoint was the pharmacokinetics following AQST-109 administration, and secondary endpoints included observed effects from 0 to 60 minutes and time to maximum effect for heart rate and blood pressure (systolic and diastolic). Children received a single 12 mg dose of AQST-109 sublingually.

With AQST-109, children experienced elevated systolic blood pressure, diastolic blood pressure, and heart rate. The times to maximum effect were the following: 11 minutes, 8 minutes, and 12 minutes, respectively.

“The pharmacokinetic profile showed that the level of epinephrine in the plasma builds up just as rapidly to just as high a level in children as it does in adults,” Golden said. “In the children, the blood pressure and heart rate were quite comparable to what we've seen in adults…this helps us to know that anaphylm in children should have the same effect, effectiveness, and safety…as what we've shown in adults.”

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.