Aquestive Therapeutics Gains FDA Support for Anaphylm

The latest update is out from Aquestive Therapeutics ( (AQST) ).

Aquestive Therapeutics, Inc. has received positive feedback from the FDA regarding its New Drug Application for Anaphylm™, an innovative sublingual film for treating severe allergic reactions. This potentially game-changing product, which could become the first orally delivered epinephrine treatment, aligns with the FDA’s guidance and requires no further adult clinical trials. With a pediatric trial underway, Aquestive plans to submit its NDA in early 2025, offering a promising alternative to traditional epinephrine devices for millions with allergies.

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