Anaphylm

Anaphylaxis is an acute systemic hypersensitivity reaction that can be fatal. In the United States the lifetime prevalence of anaphylaxis is approximately 5%. Convincing food allergy affects an estimated 10.8% of adults and 7.6% of children, and 24.0% of food-allergic adults and 40.7% of food-allergic children report a current epinephrine prescription. Case fatality was 0.25% to 0.33% among hospitalizations or emergency department presentations with anaphylaxis as the principal diagnosis, corresponding to 63 to 99 deaths per year, while multiple-cause death certificate data give 186 to 225 deaths per year. The annual economic cost of food allergy in the United States was estimated at $24.8 billion, of which $4.3 billion was direct medical cost. These estimates come from different data sources and populations and should not be combined as though they described one cohort.

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.

Aquestive Therapeutics has not announced a price for dibutepinephrine sublingual film, and no budget impact model for the product has been published. The company reports an annual revenue opportunity of more than $1 billion for the product if it is approved, within more than $1.5 billion in potential peak annual net sales across its pipeline assets. In September 2026 the company described the United States epinephrine market as reaching about 7.5 million total prescriptions and about $2.03 billion in value by 2029, citing a commercial market report and Symphony Health prescription data through December 31, 2025. Its February 2026 corporate presentation gave a current market size of about $850 million in 2025 and a projected size of about $2 billion by 2031, citing a different commercial market report, so the two company estimates of current market value differ by source.

For the eligible population, ARS Pharmaceuticals estimates approximately 40 million people in the United States with Type I allergic reactions, approximately 20 million diagnosed with severe reactions that may lead to anaphylaxis, and approximately 6.5 million prescribed an epinephrine auto-injector. At that company's list price for its intranasal epinephrine product, the 6.5 million already prescribed an auto-injector are described as an addressable opportunity of approximately $3.5 billion in annual net sales, and the remaining 13.5 million diagnosed but unprescribed people as approximately $7.0 billion. No independent analyst revenue forecast for dibutepinephrine was identified.

Aquestive Therapeutics resubmitted the new drug application for dibutepinephrine sublingual film on September 17, 2026, after a Complete Response Letter dated January 30, 2026 that requested a human factors study addressing packaging and administration and a confirmatory pharmacokinetic study. The FDA will determine the resubmission classification and the review timeline after its initial review, so no action date is established, and the product is not approved. The clinical package characterizes epinephrine exposure and hemodynamic response in healthy volunteers and in an oral allergen challenge model rather than clinical reversal of anaphylaxis, and the comparison with approved injectable products rests on pharmacokinetic bracketing. No head-to-head study against epinephrine nasal spray has been conducted. No price has been announced and no budget impact model or cost-effectiveness analysis of the product has been published, so the formulary question at this stage is whether needle-free sublingual administration and a pouch that fits in a pocket would change the proportion of reactions treated with epinephrine, at a price that is not yet known.