Name: Anaphylm (dibutepinephrine) in Type I allergic reactions including anaphylaxis: Dosage
Published: 2026-09-21T21:39:21-04:00

Product information and disease description Product description Product information Dosing and administration

Dosage

5 evidence topics · 4 sources

Film strength studied in adults and pediatric participants

“Geometric mean baseline adjusted epinephrine concentration over time after administration of Anaphylm 12mg in pediatric subjects (Study AQ109302) compared to adult subjects (Study AQ109301B)” (opens the source at this quote in a new tab)

Prodrug dose expressed as epinephrine equivalent

“AQST-109 delivers a prodrug equivalent to 12 mg of epinephrine” (opens the source at this quote in a new tab)

Single and repeat dosing across the clinical program

“The Company believes that the original Anaphylm NDA submission is supported by a comprehensive clinical development program consisting of eleven independent clinical studies with approximately 967 total administrations across 411 subjects, including 840 single-dose and 127 repeat-dose exposures of Anaphylm.” (opens the source at this quote in a new tab)

Repeat dosing evaluated in the phase 3 study

“In this 2-part, phase 3, open-label study, participants received single dose and RD of AQST-109 and epinephrine via manual syringe, EpiPen, or Auvi-Q autoinjector on different days.” (opens the source at this quote in a new tab)
“RD AQST-109 had greater than dose-proportional increases in PK and PD parameters, exceeding the comparators.” (opens the source at this quote in a new tab)

Pediatric dosing by age and weight in the completed pediatric study

“The pediatric study in subjects from the ages of 7 to 17 (weight greater than or equal to 30 kgs) was completed with positive topline data reported on April 1, 2025.” (opens the source at this quote in a new tab)