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Aquestive Therapeutics Reports Positive Topline Data from Temperature / pH Study of Anaphylm™ (epinephrine) Sublingual Film
Anaphylm pharmacokinetic results unaffected by oral cavity exposure to liquids of different temperatures and pHRemains on track to complete Anaphylm
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Anaphylm pharmacokinetic results unaffected by oral cavity exposure to liquids of different temperatures and pHRemains on track to complete Anaphylm supportive clinical studies and expects to request pre-NDA meeting with FDA in the third quarter 2024Continues to anticipate filing a New Drug Application (NDA) shortly after completion of its pediatric study of Anaphylm WARREN, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today released positive topline pharmacokinetic (PK) data from the temperature / pH study of its product candidate Anaphylm™ (epinephrine) Sublingual Film. Anaphylm is the Company’s first and only orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis. “The positive topline data from this study reinforce that Anaphylm has the potential to be seamlessly integrated into patients’ daily lives,” said Daniel Barber, President & Chief Executive Officer of Aquestive. “A recent independently conducted survey reported that 100% of patients and caregivers who participated in the survey indicated they would not return home to retrieve an autoinjector, if forgotten.1 Breaking this concerning cycle of not carrying epinephrine, the only first-line treatment for anaphylaxis, requires a product that is easy to remember, easy to carry, and easy to use even after consumption of a beverage or food. We believe Anaphylm possesses these essential attributes and has the potential to transform the lives of people at risk for severe and life-threatening allergic reactions, if approved by the FDA.” The single-dose, five-period, randomized crossover study was designed to compare the PK and pharmacodynamics (PD) of Anaphylm just after consuming normal water (hot, cold, and room temperature), lemon water, and baking soda water. The primary PK parameters were the maximum amount of epinephrine measured in plasma (Cmax) and exposure, or the area under the curve (AUC), at various times after dosing, in 30 healthy adult subjects. Topline PK data from the study showed no statistically significant difference in PK results base...