Dec. 6 at 3:10 PM
$AQST Epinephrine Sublingual Film for Severe Allergic Reactions
PDUFA date: January 31, 2026
The NDA for Anaphylm, a sublingual film formulation of epinephrine, is under review for the treatment of Type 1 allergic reactions, including anaphylaxis.
Anaphylm is a polymer matrix-based film designed to dissolve rapidly and deliver epinephrine systemically. If approved, it would be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, offering a needle-free alternative.
The NDA submission is supported by a comprehensive clinical data package that includes a pharmacokinetics (PK) study in healthy adults, a pediatric PK study, and supportive data from a temperature study, a self-administration study, and an allergen study. Anaphylm resulted in rapid resolution of symptoms beginning 2 minutes after administration.
https://www.empr.com/news/fda-drug-approval-decisions-expected-in-january-2026/
