Anaphylm (dibutepinephrine)

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.