Aquestive Therapeutics has received a Complete Response Letter (CRL) from the U.S. FDA for Anaphylm (dibutepinephrine) Sublingual Film due to deficiencies in its labeling and administration.
Anaphylm is intended to treat Type 1 allergic reactions in patients weighing at least 30 kg. A human factors (HF) validation study of the medication revealed issues with opening the pouch and incorrect film placement. The FDA is concerned that these could lead to safety issues if a patient is suffering from anaphylaxis.
Aquestive has said that it will be able to resolve the deficiencies soon, including by modifying the pouch opening, clarifying usage instructions, and changing the pouch and carbon labeling. The next step is to conduct a subsequent HF validation study. The company plans to resubmit as early as Q3 2026, when it will also address potential tolerability issues. Aquestive will be requesting a Type A meeting with the FDA to determine how to make the resubmission as efficient as possible.