Aquestive Therapeutics (AQST), a pharmaceutical company, announced on Monday that it has received positive feedback from the FDA regarding its planned New Drug Application submission for Anaphylm (epinephrine) Sublingual Film, an investigational treatment for severe allergic reactions, including anaphylaxis.
Anaphylm is designed to be the first orally delivered epinephrine treatment for anaphylaxis, providing a convenient, easy-to-carry alternative to current injectable epinephrine devices.
The FDA confirmed that no additional adult clinical trials are required before the NDA submission, and the company has already commenced a pediatric trial in the U.S. and Canada.
The NDA submission is planned for the first quarter of 2025.
The FDA agreed on the submission format and safety evaluation plans, requesting minor modifications to the pediatric trial protocol.
The FDA also emphasized the need for pharmacokinetic sustainability for a single dose and noted that an advisory committee meeting may be necessary due to the novel route of administration.
The company reiterated its plan for a full product launch of Anaphylm, if approved by the FDA, by the end of 2025 or early 2026.
If approved, Anaphylm could offer a groundbreaking treatment option for the estimated 33 million Americans with food allergies, addressing a significant gap in available therapies.
AQST closed Friday's trading at $5.09, down 1.36%. In premarket trading today, the stock is down by 1.74% at $5.00.
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