Aquestive Therapeutics (AQST) reported positive topline pharmacokinetic data from the temperature / pH study of its product candidate Anaphylm Sublingual Film. Anaphylm is the company's first orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis.
"We anticipate that, before the end of the third quarter, the adult studies that we believe are necessary for a robust NDA filing will be complete. We plan on requesting a pre-NDA meeting with the FDA upon receipt of topline data. We continue to anticipate conducting our pediatric study for Anaphylm in the fourth quarter 2024, if agreed upon with the FDA, and filing shortly thereafter," said Daniel Barber, President & Chief Executive Officer of Aquestive.
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