Aquestive Therapeutics, (previously MonoSolRX), known for specializing in the development and commercialization of products that meet unmet needs for patients, has announced positive topline data from its first-in-human Phase 1 PK study of AQST-109 sublingual film for the delivery of epinephrine in the urgent treatment of allergic reactions including anaphylaxis. Initial data from the study suggests that AQST-109 has the potential to be the first orally administered epinephrine treatment for anaphylaxis. AQST-109 is a polymer matrix-based film that dissolves upon contact and is administered under the tongue for the fast release of epinephrine. Aquestive presented its application for a pre-investigational new drug (IND) appointment with the U.S. Food and Drug Administration (FDA).

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