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

Pediatric participants aged 7 to 17 years weighing at least 30 kilograms

“today announced positive topline results from its pediatric study for Anaphylm™ (epinephrine) sublingual film in patients aged seven to seventeen and weighing greater than thirty kilograms with a personal history of allergic reactions.” (opens the source at this quote in a new tab)
“These data are an important component of the FDA review process and could enable Anaphylm to have a label that includes this pediatric patient population.” (opens the source at this quote in a new tab)

Pediatric study design and completion

“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. A total of thirty-two patients completed the study.” (opens the source at this quote in a new tab)

“The pediatric study was a multi-site, single treatment study designed to evaluate the PK, pharmacodynamics (PD), safety, and tolerability of Anaphylm.” (opens the source at this quote in a new tab)

Epinephrine class: pregnancy

“Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with anaphylaxis, and treatment with epinephrine should not be delayed” (opens the source at this quote in a new tab)
“During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. Treatment of anaphylaxis during pregnancy should not be delayed.” (opens the source at this quote in a new tab)

Epinephrine class: lactation

“There are no data on the presence of epinephrine or its metabolite in human milk, the effects on the breastfed infant, or the effects on human milk production. However, due to its poor oral bioavailability and short half-life, transfer of epinephrine into breastmilk is expected to be low. Treatment for anaphylaxis in breastfeeding patients should not be delayed.” (opens the source at this quote in a new tab)

Epinephrine class: older adults

“Clinical studies of EpiPen or EpiPen Jr for the emergency treatment of type I allergic reactions, including anaphylaxis, were not conducted in subjects aged 65 and over to determine whether they respond differently from younger adult subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine.” (opens the source at this quote in a new tab)

Epinephrine class: organ contributions to elimination

“Epinephrine is rapidly degraded to vanillylmandelic acid, an inactive metabolite, by monoamine oxidase and catechol-O-methyltransferase that are abundantly expressed in the liver, kidneys and other extraneuronal tissues. The tissues with the highest contribution to removal of circulating exogenous epinephrine are the liver (32%), kidneys (25%), skeletal muscle (20%), and mesenteric organs (12%).” (opens the source at this quote in a new tab)

Populations excluded from the phase 1 program

“The Phase 1 trials conducted by AQST excluded patients with CV disease, mucosal disease, concomitant medications, or other comorbidities.” (opens the source at this quote in a new tab)

Hepatic and renal impairment: dedicated studies of dibutepinephrine

No evidence found.