Aquestive Therapeutics aligns with the U.S. Food and Drug Administration on PK and human factors studies to support Anaphylm NDA resubmission, targeting Q3 2026 filing.
Written By: Pharmacally Medical News Desk
Aquestive Therapeutics has clarified the regulatory path for its epinephrine sublingual film, Anaphylm™ (dibutepinephrine), after detailed discussions with the U.S. Food and Drug Administration on requirements for NDA resubmission. The meeting was aimed at clarifying the regulatory expectations for resubmitting the New Drug Application (NDA) after previous feedback from the agency.
The interaction provided detailed direction on how the company should refine its clinical and usability data package, particularly focusing on pharmacokinetic (PK) and human factors (HF) studies. These components are critical for demonstrating that Anaphylm can deliver reliable epinephrine exposure and be used correctly by patients during emergency situations such as anaphylaxis.
From a PK perspective, the FDA emphasized the importance of maintaining consistency with earlier studies conducted by the company. This includes alignment in study design, dosing conditions, and evaluation parameters to ensure that the new data can be directly compared with previously submitted results. Aquestive had already shared its proposed PK study design ahead of the meeting and received preliminary feedback, which it now plans to fully incorporate. This step is essential to strengthen the overall clinical package and avoid discrepancies that could delay review.
A notable outcome of the discussion was the FDA’s agreement on managing certain real-world usage scenarios through labeling rather than requiring additional clinical trials. Specifically, the potential for patients to chew the sublingual film, which could alter drug absorption, will be addressed through clear instructions in the product label. This approach reduces the need for further clinical burden while still ensuring patient safety and proper use.
In parallel, the FDA provided input on the design of the HF validation study, which evaluates how effectively patients and caregivers can use the product in real-life conditions. The agency recommended adjustments to the selection of user groups to better reflect the intended population, including individuals who may use the product in high-stress emergency settings. Following the meeting, Aquestive indicated that it has reached general alignment with the FDA on the key elements of the HF study and will submit the final protocol for formal review.
The company also used the meeting to present improvements made to Anaphylm’s packaging, particularly the pouch opening mechanism. These changes are designed to make the product easier to access quickly while reducing the risk of damaging the film during handling. The updated design will be formally tested as part of the HF study to confirm that it meets usability expectations.
Based on the clarity gained from the Type A meeting, Aquestive reaffirmed its plan to resubmit the Anaphylm NDA in the third quarter of 2026. At the same time, the company is advancing regulatory filings in Canada and the European Union, reflecting a broader global strategy for the product.
In earlier regulatory interactions, the U.S. Food and Drug Administration had identified certain gaps in the Anaphylm™ NDA package, including areas related to clinical and usability data expectations. Separately, the agency later issued a Complete Response Letter (CRL), raising additional concerns that required further data and clarification before approval could be considered. Following the CRL, Aquestive Therapeutics outlined its plan during a subsequent financial update to address these issues and pursue a resubmission strategy. The latest Type A meeting reflects progress in that effort, with clearer alignment on the remaining requirements.
Anaphylm is a polymer matrix-based epinephrine prodrug formulated as a small, rapidly dissolving sublingual film. Unlike traditional injectable epinephrine products, it does not require needles, water, or swallowing, making it a potentially more accessible and user-friendly option in emergency situations. Its compact, weather-resistant packaging further supports portability, which is critical for patients at risk of sudden, severe allergic reactions.
Reference
Aquestive Therapeutics Announces Completion of Type A Meeting with FDA for Anaphylm™ (dibutepinephrine) Sublingual Film, 30 March 2026, Aquestive Therapeutics Announces Completion of Type A Meeting with FDA for Anaphylm™ (dibutepinephrine) Sublingual Film – Aquestive Therapeutics