Aquestive Therapeutics resubmitted its New Drug Application (NDA) to the FDA for Anaphylm. This under-the-tongue film treats severe allergic reactions, including anaphylaxis. If approved, Anaphylm would be the first needle-free, orally-delivered epinephrine product available to patients.
The resubmission follows a Complete Response Letter (CRL) issued by the FDA on January 30, 2026. The agency did not raise concerns regarding the drug's effectiveness or safety. Instead, the CRL cited deficiencies in product packaging and the time required to open the pouch during an emergency.
Aquestive conducted new studies with revised packaging and instructions to address the FDA's findings. The company successfully reduced the median time to open the pouch to 3 seconds. This marks a significant improvement from the previous median opening time of 17 seconds.