Aquestive resubmits FDA application for Anaphylm epinephrine film

Aquestive Therapeutics announced on September 17, 2026 that it has resubmitted its New Drug Application to the FDA for Anaphylm (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis.¹

The company's original NDA for Anaphylm was submitted in March 2025.¹ The FDA responded with a Complete Response Letter, and that letter, dated January 30, 2026, asked Aquestive to complete a human factors study addressing packaging and administration along with a confirmatory pharmacokinetic study.¹ Following the letter, Aquestive held a Type A meeting with the FDA to discuss its proposed approach to resolving the issues raised.¹

In response, Aquestive ran a human factors study that tested a redesigned package, changing how the pouch opens along with updated instructions and labeling on both the pouch and carton, according to the filing. The company also ran a confirmatory pharmacokinetic study in healthy volunteers using the revised packaging and instructions, testing both self-administration and clinician administration of Anaphylm with manual intramuscular epinephrine included as a comparator.¹ No protocol-defined use errors occurred in the self-administration arm of that study.¹

CEO Daniel Barber said the studies produced human factors, pharmacokinetic, and pharmacodynamic data supporting the new packaging and instructions, and pointed to a drop in median pouch-opening time from 17 seconds to 3 seconds. Barber said the resubmission reflects the company's response to the FDA's Complete Response Letter and that it believes the submission addresses the items the FDA identified.¹

The FDA has not yet set a review timeline. The agency will determine the resubmission's classification and establish the applicable review timeline after its initial review.¹ Anaphylm's proposed trade name has received conditional FDA approval, with final approval contingent on the product itself being approved.¹