On March 30, 2026, Aquestive Therapeutics announced the successful completion of a critical Type A meeting with the US Food and Drug Administration (FDA). This meeting focused on the path forward for the resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film. Following a previous Complete Response Letter (CRL), the company has been working to address specific concerns regarding the product’s administration and packaging to ensure it meets the rigorous safety standards required for a rescue medication.
The meeting provided Aquestive with necessary clarifying feedback on the design of upcoming pharmacokinetic (PK) and human factor (HF) studies. These studies are essential to prove that the medication’s oral film delivery remains effective and user-friendly even after the company’s recent adjustments to the product’s packaging. Daniel Barber, President and Chief Executive Officer of Aquestive, expressed optimism regarding the interaction, stating, “The Type A Meeting with FDA confirmed our approach on several key program elements, and we are grateful to the Agency for the productive dialogue on the next steps for our Anaphylm program.”
A major highlight of the discussion was the alignment between Aquestive and the FDA on product labeling. Rather than requiring extensive new clinical data to address the potential for patients to chew the film, the FDA agreed that clear labeling language could sufficiently manage this risk. This agreement streamlines the regulatory process, allowing the company to focus its resources on the primary validation studies. Barber noted the urgency of the team’s efforts, saying, “We are already hard at work preparing for our human factors and PK studies in support of our planned Anaphylm NDA resubmission in the third quarter of this year.”
In response to the FDA’s initial concerns about the difficulty of opening the medication’s pouch, Aquestive showcased revisions to the container’s closure mechanism. The new design is intended to make the pouch easier to open in an emergency while preventing the delicate film from tearing. The FDA acknowledged these changes, which will be formally tested in the upcoming HF study. This focus on the “patient experience” is a central pillar of the resubmission strategy, as the drug is intended for use during high-stress anaphylactic events.
Beyond the technical requirements, the company reaffirmed its broader mission to provide a non-invasive alternative to traditional epinephrine auto-injectors. Anaphylm is designed to be the first oral rescue medication of its kind, roughly the size of a postage stamp and capable of dissolving on contact without water. Highlighting the impact of this innovation, Barber remarked, “We continue to believe Anaphylm, the first and only oral epinephrine rescue medication, has the potential to be transformative for those at risk of life-threatening allergic reactions.”
The company also extended its gratitude to the medical and patient communities that have supported the development of Anaphylm. As the only oral option currently in late-stage development, the product has garnered significant interest from those seeking an “easy-to-carry” and “fast-acting” treatment. “We want to thank the many patients, healthcare providers, and patient advocacy organizations who have expressed support for our program. Our commitment to address the long-unmet needs of this community remains strong,” Barber added.
With the Type A meeting concluded, Aquestive is now awaiting the final official minutes from the FDA, which are expected by early May 2026. Despite the setback of the earlier CRL, the company remains on a steady trajectory, reaffirming its guidance to resubmit the Anaphylm NDA in the third quarter of 2026. If successful, Aquestive is well-positioned to finally bring this long-awaited, needle-free epinephrine delivery system to the global market.
