Aquestive Advances Anaphylm With Positive Study Results

The latest update is out from Aquestive Therapeutics ( (AQST) ).

On August 10, 2026, Aquestive Therapeutics furnished an updated investor presentation to institutional investors and analysts, signaling active engagement with the market around its development programs and regulatory strategy. The materials, which can be amended over time, underscore the company’s effort to position its oral film technologies and allergy-focused portfolio with stakeholders.

On the same date, the company reported positive topline results from a new human factors validation study and pharmacokinetic study for Anaphylm, its sublingual epinephrine prodrug film for Type 1 allergic reactions including anaphylaxis. The data directly address deficiencies cited in an FDA Complete Response Letter issued in January 2026 and are intended to support a planned resubmission of the Anaphylm New Drug Application in the third quarter of 2026.

The revised packaging design cut median pouch opening time from 17 seconds to 3 seconds, sharply reduced difficulty opening and incorrect film placement, and eliminated chewing or removal of the film in the study. A pharmacokinetic study in healthy volunteers showed that self-administration delivered exposure comparable to clinician-administered Anaphylm and faster time to peak concentration than manual intramuscular epinephrine, with no administration errors and no serious adverse events.

At the FDA’s request, Aquestive also tested deliberately incorrect placement of Anaphylm on top of the tongue, finding lower and delayed drug levels but pharmacodynamic effects, including blood pressure changes, comparable to or greater than injectable epinephrine. This robustness to real-world use errors, combined with improved usability and tolerability, strengthens Anaphylm’s profile and could enhance patient confidence and adoption if the product ultimately secures approval.

Aquestive plans to include the human factors and pharmacokinetic data in its upcoming NDA resubmission while simultaneously advancing regulatory filings for Anaphylm in Canada, the U.K., and the European Union. For investors and patients, the positive studies mark a notable step toward bringing what could become the first non-invasive, orally delivered epinephrine treatment for life-threatening allergic reactions to market, potentially reshaping emergency allergy care and reinforcing Aquestive’s positioning in drug delivery innovation.