Aquestive Therapeutics Completes FDA Meeting, Plans to Resubmit NDA in Q3 2026

Aquestive Therapeutics announced the receipt of preliminary comments and successful completion of an in-person Type A meeting with the FDA regarding the resubmission of the company's new drug application, or NDA, for Anaphylm sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis. Aquestive provided the proposed PK study design to the FDA prior to the Type A meeting and received preliminary comments in advance of the meeting. Most of the preliminary comments provided by the FDA were focused on ensuring consistency between past PK studies conducted by the company and the proposed current design. The company plans to address all feedback received by the Agency in the PK study design. In addition, the company and FDA aligned on the concept of including labeling language to manage potential chewing of the film rather than creating additional clinical data. The FDA also provided preliminary comments on Aquestive's HF validation study design provided by the company to the FDA prior to the meeting. The FDA recommended changes to the user groups to be included in the HF study design and, after discussion at the Type A meeting, the company believes there is general alignment with the FDA on key HF study elements. Aquestive plans to submit the HF study protocol for FDA review, as recommended by the FDA. During the meeting, the company shared with the FDA the revisions made to the opening mechanisms of the product container closure, which were designed to provide improvements in the ability to open the pouch while also mitigating the potential tearing of the film. The FDA acknowledged the changes made to the Anaphylm container closure, which will be tested in the company's upcoming HF study. Based on the outcome of the Type A meeting, Aquestive reaffirms its guidance to resubmit the Anaphylm NDA in the third quarter of 2026. The company also continues to advance regulatory submissions for Anaphylm in Canada and the European Union. Anaphylm has the potential to be the first and only FDA-approved, non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis.