Aquestive Therapeutics Concludes FDA Application For Allergy Drug With Encouraging Pediatric Trial Data

Aquestive Therapeutics, Inc. AQST released topline results from its pediatric study for Anaphylm (epinephrine) sublingual film in patients aged seven to seventeen and weighing over 30 kgs with a personal history of allergic reactions.

This marks the completion of the Anaphylm clinical program and supports the clinical data needed for the new drug application (NDA) submission.

Aquestive has submitted the Anaphylm NDA to the U.S. Food and Drug Administration (FDA) and expects to receive potential acceptance of the NDA during the second quarter of 2025.

Also Read: Developer Of EpiPen Alternative Aquestive Stock Undervalued Despite Strong Clinical Data, Analyst Sees Huge Upside

Anaphylm (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate in development for severe allergic reactions, including anaphylaxis.

Anaphylm is similar to a postage stamp, weighs less than an ounce and begins to dissolve on contact. No water or swallowing is required for administration.

The packaging for Anaphylm is thinner and smaller than an average credit card. It can be carried in a pocket and is designed to withstand weather excursions such as exposure to rain and/or sunlight.

The FDA has conditionally approved the Anaphylm trade name for AQST-109. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.

Thirty-two patients completed the pediatric study. The PK results were consistent with previous adult studies.

Anaphylm was safe and well-tolerated, and no serious adverse events (SAEs) were reported.

Anaphylm pre-commercial activities are underway; launch is expected in Q1 2026 if approved by the FDA.

Price Action: AQST stock is up 0.34% at $2.91 at the last check on Tuesday.

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