Aquestive Therapeutics

New Capabilities

Received FDA Complete Response Letter; resubmitting NDA in Q3 2026 after human factors and PK studies

For nearly four decades, Americans facing life-threatening allergic reactions had exactly one option: stab themselves with a needle. The EpiPen and its competitors delivered epinephrine effectively, but needle phobia kept roughly 30% of patients from using their prescribed devices during emergencies—contributing to preventable deaths. Now the needle era is ending. The Food and Drug Administration (FDA) approved the first needle-free alternative, a nasal spray called neffy, in August 2024. On February 2, 2026, the FDA issued a Complete Response Letter for Anaphylm, a dissolvable film placed under the tongue, rejecting the application but limiting deficiencies to human factors and packaging rather than safety or efficacy concerns. Aquestive Therapeutics expects to resubmit in the third quarter of 2026 after conducting a redesigned human factors validation study and a supporting pharmacokinetics study.

Updated Feb 5