Aquestive Therapeutics (NASDAQ: AQST) announced topline results from its human factors validation study and pharmacokinetic study for Anaphylm (dibutepinephrine) sublingual film, a drug candidate for the treatment of Type 1 allergic reactions, including anaphylaxis. The company plans to use the data in support of a New Drug Application resubmission to the U.S. Food and Drug Administration, targeted for the third quarter of 2026.

The company received a Complete Response Letter from the FDA in January 2026, which identified deficiencies in a prior human factors study, including difficulty opening the pouch, film tearing, incorrect film placement, chewing, and premature removal. The revised study showed improvements across each area. The median time to open the pouch decreased from 17 seconds to 3 seconds. The number of participants who had difficulty opening the pouch fell from 26 out of 166 to 1 out of 105. Incorrect film administration in the mouth dropped from 20 out of 166 participants to 2 out of 105. No participants in the latest study were observed chewing or removing the film.

In the pharmacokinetic study, self-administered Anaphylm produced a geometric mean maximum concentration of 391.7 pg/mL with a median time to peak concentration of 12 minutes. Clinician-administered Anaphylm showed a geometric mean maximum concentration of 357.6 pg/mL, also at 12 minutes. Manual intramuscular epinephrine produced a geometric mean maximum concentration of 334.5 pg/mL at a median of 45 minutes. No administration errors were observed in the self-administration arm.

A separate pharmacokinetic arm studied intentional incorrect placement of the film on top of the tongue, as requested by the FDA. That arm showed a geometric mean maximum concentration above 100 pg/mL and a median time to peak concentration of 35 minutes, with pharmacodynamic results described as comparable to or greater than those observed with injectable epinephrine.

No serious adverse events were reported in the pharmacokinetic study. Aquestive said it is also advancing regulatory submissions for Anaphylm in Canada, the United Kingdom, and the European Union.