Sublingual Epinephrine Shows Fastest, Most Consistent Absorption in Adults and Children
Data from 2 open-label clinical trials suggest that sublingual epinephrine may offer a faster and more consistent pharmacokinetic profile than traditional intramuscular (IM) injection or autoinjectors, including EpiPen and Auvi-Q.
The findings, presented at the American College of Allergy, Asthma & Immunology 2025 Annual Scientific Meeting support sublingual delivery as a promising alternative for anaphylaxis management, particularly in settings where precision and rapid action are critical.
In the adult trial (n=64) and pediatric trial (n=32), researchers compared median time to peak plasma concentration (Tmax), peak concentration (Cmax), and total exposure (AUC) across delivery methods. In both cohorts, sublingual epinephrine demonstrated the fastest median Tmax of 12 minutes with an interquartile range (IQR) of 5.0 minutes. By comparison, median Tmax for EpiPen was 20 minutes (IQR 25 min), Auvi-Q was 30 minutes (IQR 32 min), and manual IM injection was 50 minutes (IQR 15 min).
“Sublingual epinephrine achieved the fastest median Tmax (12 min), with the narrowest IQR (5 min), indicating the tightest clustering of individual responses,” the authors reported.
This reduced interpatient variability may translate into more predictable clinical outcomes. In both adult and pediatric participants, the pharmacokinetic profile of the investigational sublingual formulation—Anaphylm—was consistently more reliable than those of autoinjectors or IM injections.
According to the study, “Anaphylm’s PK consistency suggests potentially greater clinical dependability than currently available autoinjectors, if approved.”
These findings underscore the potential of sublingual administration to address known limitations of current epinephrine delivery options, particularly the wide variability in absorption and patient response. Further studies are warranted to evaluate clinical efficacy in emergency scenarios.
Reference
Sublingual epinephrine provides consistent pharmacokinetics in both adult and pediatric subjects. Presented at: American College of Allergy, Asthma & Immunology 2025 Annual Scientific Meeting; November 6-10, 2025; Orlando, FL.
