Anaphylm (dibutepinephrine)

No study has measured reversal of an anaphylactic episode with dibutepinephrine, so the evidence base is pharmacokinetic and pharmacodynamic. In the two-part phase 3 study AQ109301, 64 participants were enrolled in the single-dose part and 36 in the repeat-dose part. A single 12 mg film produced a geometric mean maximum serum concentration of 470 pg/mL, bracketed by Auvi-Q at 521 pg/mL and EpiPen at 469 pg/mL, with a median time to maximum concentration of 12 minutes compared with 20 minutes for EpiPen, 30 minutes for Auvi-Q, and 50 minutes for manual intramuscular injection. Blood pressure and heart rate rose more rapidly and to a greater degree than with the comparators, and repeat dosing produced greater than dose-proportional increases in both. In the phase 2 OASIS study in participants undergoing oral allergen challenge, pharmacokinetic values were similar with and without challenge, and the median time to complete resolution of allergen-induced oral symptoms was 12 minutes compared with 74 minutes at screening. A pediatric study in participants aged seven to seventeen weighing more than 30 kg reported a consistent pharmacokinetic profile. No serious adverse events were reported in the phase 3 study. In the human factors and confirmatory pharmacokinetic studies completed in 2026, median pouch-opening time fell from 17 seconds to 3 seconds and no protocol-defined use errors were observed in the self-administration arm.