Bioavailability of epinephrine from Auvi-Q compared with EpiPen

Abstract

BackgroundEpinephrine autoinjectors are underused for the treatment of anaphylaxis in community settings. Auvi-Q, a novel epinephrine autoinjector, was designed to be intuitive to use and reduce the potential for use-related errors. ObjectiveTo compare the bioavailability of 0.3 mg of epinephrine (adrenaline) injected with Auvi-Q and EpiPen in healthy adults. MethodsIn this randomized, single-blind, 2-treatment, 3-period, 3-sequence crossover study, healthy adults (18-45 years old) received a single injection of 0.3 mg of epinephrine with Auvi-Q in one period and with EpiPen in the other 2 periods. Blood samples were obtained before and 14 times during 6 hours after the dose. Outcomes included peak plasma concentration (Cmax), total epinephrine exposure (area under the concentration-time curve [AUC] from baseline to the last measurable concentration [AUC0-t] and extrapolated to infinity [AUCinf]), and adverse events. ResultsSeventy-one volunteers (53 male, 74.6%), with a mean age of 33.2 years and a mean body mass index of 25.4, were randomized. Epinephrine peak concentration and total exposure were similar between Auvi-Q (Cmax = 0.486 ng/mL; AUC0-t = 0.536 ng·h/mL; AUCinf = 0.724 ng·h/mL) and EpiPen (Cmax = 0.520 ng/mL; AUC0-t = 0.466 ng·h/mL; AUCinf = 0.583 ng·h/mL). Cmax and AUC analyses demonstrated bioequivalence between Auvi-Q and EpiPen. Most treatment-emergent adverse events were mild (98%), and all resolved spontaneously. Rates of injection-site pain and bleeding were 13% and 5%, respectively, for Auvi-Q vs 24% and 10%, respectively, for EpiPen. ConclusionAfter a single injection of 0.3 mg of epinephrine, Auvi-Q and EpiPen had similar peak and total epinephrine exposure, were bioequivalent, and had similar safety profiles.