AQST - Aquestive IND for AQST-109 cleared by FDA to enter trial for allergic reactions

Aquestive Therapeutics (NASDAQ:AQST) said the U.S. Food and Drug Administration (FDA) cleared its investigational new drug application (IND) for AQST-109 epinephrine oral film to enter clinical trial. The company intends to explore AQST-109, an epinephrine prodrug used as a sublingual film, to treat severe allergic reactions, including anaphylaxis — a severe, potentially life-threatening allergic. “We are pleased that the FDA has cleared our IND to allow clinical investigation in the U.S. and look forward to continuing to advance the development program of this transformative therapeutic option for the emergency treatment of severe allergic reactions, including anaphylaxis,” said Aquestive CEO Keith Kendall. in December 2021, the company's stock slumped following FDA's decision to delay the review of its drug Libervant to treatment of breakthrough seizures and seizure clusters.

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Aquestive IND for AQST-109 cleared by FDA to enter trial for allergic reactions