Aquestive Therapeutics announced that the US Food and Drug Administration (FDA) has accepted its resubmitted application for Anaphylm™ (dibutepinephrine), a dissolvable film being developed to treat serious allergic reactions, including life-threatening anaphylaxis. The FDA classified the application as a Class 2 resubmission and set a target decision date of March 16, 2027. If approved, Anaphylm would offer patients another needle-free alternative to traditional epinephrine injections.
The renewed review follows a January 30, 2026, Complete Response Letter from the FDA, which identified issues that prevented the agency from approving the original application. In August, Aquestive announced positive preliminary results from additional studies examining how people use the product and how the medication is absorbed into the bloodstream. The company incorporated the new findings into its revised application, submitted on September 16. The FDA must now determine whether the additional evidence adequately addresses its concerns.
“The FDA’s acceptance of our resubmission and the assignment of a Class 2 PDUFA date as expected gives us a clear path forward for Anaphylm,” said Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics. “For decades, people at risk of anaphylaxis have had limited treatment options. Anaphylm, if approved, would represent a new level of innovation designed to comprehensively address patient needs, with the goal of providing patients and caregivers with an epinephrine treatment they can carry and use confidently, whether at school, at work, or while traveling.”
Aquestive is already preparing for a potential commercial launch while awaiting the FDA’s decision. “We believe Anaphylm has the potential to be an important new treatment option for patients and caregivers, and we are focused on making Anaphylm available as quickly as possible, if approved,” Barber added. “In parallel, we are advancing our commercial preparations so that we are ready for the potential launch of Anaphylm, if approved.”
If approved, Anaphylm would become the first and only orally administered rescue medication for severe allergic reactions. Instead of an injection, the treatment consists of a thin film placed under the tongue, where it begins dissolving on contact without requiring water or swallowing. The film contains dibutepinephrine, a substance designed to convert into active epinephrine after entering the body. Epinephrine is the first-line treatment for anaphylaxis, a potentially fatal allergic reaction that requires immediate attention.
Portability is one of Anaphylm’s biggest advantages. Approximately the size of a postage stamp and weighing less than an ounce, the film comes in packaging smaller and thinner than an average credit card. It is designed to fit conveniently into a wallet or phone case, with protective packaging intended to withstand everyday weather exposure, including rain and sunlight. For people who must carry emergency epinephrine wherever they go, such a compact option could make it easier to keep treatment close at hand.
Aquestive is also pursuing approval outside the United States, with plans to complete its New Drug Submission to Health Canada during the fourth quarter of 2026. For now, Anaphylm remains an investigational treatment and is not FDA-approved. People at risk of anaphylaxis should continue carrying their prescribed, approved epinephrine treatments and following their emergency action plans while the FDA completes its review.
