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Aquestive Therapeutics to Present Anaphylm™ (epinephrine) Sublingual Film Pharmacokinetic and Pharmacodynamic Data at the 2024 AAAAI Annual Meeting
The clinical trial data show that epinephrine delivered via orally administered Anaphylm™ (epinephrine) Sublingual Film is comparable to epinephrine delivered
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"The clinical trial data show that epinephrine delivered via orally administered Anaphylm™ (epinephrine) Sublingual Film is comparable to epinephrine delivered via autoinjector or manual intramuscular (IM) injection.Anaphylm candidate, with the potential to be the first and only non-invasive, orally delivered epinephrine product, demonstrates clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of severe allergic reactions, including anaphylaxis. A Phase 3 pivotal study for Anaphylm is currently underway with topline data anticipated in the first quarter of 2024. WARREN, N.J., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced a poster presentation highlighting the positive pharmacokinetic (PK) and pharmacodynamic (PD) data from two completed clinical studies for Anaphylm will be presented at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2024 annual meeting, which will take place February 23-26 in Washington, D.C. As highlighted in the abstract, Anaphylm PK and PD data were comparable to epinephrine delivered via autoinjector or manual intramuscular injection (IM). “With discovery and innovation as key themes of this year’s meeting, we are eager to present our latest clinical trial data at the upcoming AAAAI Annual Meeting,” said Dan Barber, Aquestive President and Chief Executive Officer. “With the potential to be the first and only needle-free orally administered epinephrine, Anaphylm is poised to transform the treatment of severe/life-threatening allergic reactions, if approved by the FDA.” “The data from the Anaphylm studies expands the favorable evidence indicating that epinephrine delivered via sublingual film results in a rapid onset of action with an early, robust increase in pharmacokinetic and pharmacodynamic parameters used to measure epinephrine efficacy,” stated David Golden, M.D., Allergist & Immunologist at Medstar Franklin Square Hospital, Baltimore, Maryland. “These results demonstrate that Anaphylm shows promise as a viable needle-free alternative for the treatment of Type I allergic reactions.” Poster Title: Pharmacokinetic...