Aquestive Completes FDA Type A Meeting, Prepares To Resubmit Anaphylm NDA In Q3 2026 For First Oral Epinephrine Rescue Treatment

Aquestive Therapeutics, Inc. announced that it has received preliminary feedback and successfully completed an in-person Type A meeting with the U.S. Food and Drug Administration regarding the company’s plan to resubmit its New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film. This medication is being developed for the treatment of Type 1 allergic reactions, including anaphylaxis, and is intended to offer a non-invasive alternative to traditional epinephrine rescue products.

Daniel Barber, President and Chief Executive Officer of Aquestive, said the meeting helped confirm their strategy for moving the Anaphylm program forward. He noted that the company is already preparing for its upcoming human factors (HF) and pharmacokinetic (PK) studies, which will support the planned NDA resubmission in the third quarter of this year. Barber emphasized that Anaphylm, positioned as the first and only oral epinephrine rescue option, could greatly benefit people at risk of life-threatening allergic reactions. He also expressed appreciation for the support shown by patients, healthcare professionals, and advocacy groups, reinforcing the company’s commitment to addressing long-standing gaps in allergy care.

Ahead of the Type A meeting, Aquestive shared its proposed PK study design with the FDA and received early comments. Most of the feedback focused on ensuring the study remained consistent with previous PK work conducted by the company. Aquestive plans to incorporate all FDA guidance into the final PK study design. Both parties also agreed that labeling instructions to address the possibility of patients chewing the sublingual film would be more appropriate than generating additional clinical data.

The FDA also provided initial comments on Aquestive’s human factors validation study design. During the meeting, the agency recommended adjustments to the user groups included in the study. Following discussion, the company believes there is general alignment on the major elements of the HF study, and it plans to submit the protocol to the FDA for review as recommended. Aquestive also presented updates to the opening mechanism of the product’s pouch, which were created to make it easier to open while reducing the chance of damaging the film. The FDA acknowledged these design improvements, which will be assessed in the upcoming HF study.