Oral Allergy Medication For Emergencies - Aquestive Therapeutics' Investigational Therapy Works Even With Exposure To Liquids Of Different Temperatures, Data Shows
Oral Allergy Medication For Emergencies - Aquestive Therapeutics' Investigational Therapy Works Even With Exposure To Liquids Of Different Temperatures, Data Shows
On Tuesday, Aquestive Therapeutics Inc (NASDAQ:AQST) released topline pharmacokinetic (PK) data from the temperature / pH study of its product candidate Anaphylm (epinephrine) Sublingual Film.
週二，Aquestive Therapeutics Inc（納斯達克股票代碼：AQST）發佈了其候選產品Anaphylm（腎上腺素）舌下薄膜溫度/pH研究的主要藥代動力學（PK）數據。
Anaphylm is the company's first and only orally administered epinephrine prodrug product candidate under development for severe life-threatening allergic reactions, including anaphylaxis.
Anaphylm是該公司第一個也是唯一一個正在開發的用於嚴重危及生命的過敏反應（包括過敏反應）的口服腎上腺素前藥候選產品。
In March, Aquestive Therapeutics released topline clinical data from its Phase 3 PK study of Anaphylm, meeting all primary and secondary pharmacokinetic endpoints.
3月，Aquestive Therapeutics發佈了其對Anaphylm的3期藥代動力學研究的主要臨床數據，該研究符合所有主要和次要藥代動力學終點。
Pharmacokinetics is the movement of drugs into, through, and out of the body.
藥代動力學是藥物進入體內、通過體內和流出體內。
The single-dose, five-period, randomized crossover study was designed to compare the PK and pharmacodynamics (PD) of Anaphylm just after consuming normal water, lemon water, and baking soda water.
這項單劑量、五週期、隨機交叉研究旨在比較Anaphylm在飲用普通水、檸檬水和小蘇打水後的PK和藥效學（PD）。
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.
主要的PK參數是30名健康成年受試者給藥後不同時間在血漿（Cmax）和暴露量或曲線下方區域（AUC）中測得的最大腎上腺素量。
Topline PK data from the study showed no statistically significant difference in PK results based on changes in temperature and pH.
該研究的Topline PK數據顯示，基於溫度和pH值的變化，PK結果沒有統計學上的顯著差異。
The most consumed beverages, such as soda, milk, coffee, and juice, have acidity between lemon water and normal water.
消費最多的飲料，例如蘇打水、牛奶、咖啡和果汁，其酸度介於檸檬水和普通水之間。
While not statistically significant, alkaline substances like baking soda showed a somewhat higher absorption level than room-temperature water.
雖然不具有統計學意義，但小蘇打等鹼性物質的吸收水平略高於室溫水。
"Patients experiencing an allergic reaction must have confidence that their rescue medication will provide sufficient medicine as quickly as possible and without fail," said Eleanor Garrow-Holding, President & CEO of Food Allergy & Anaphylaxis Connection Team.
食物過敏與過敏反應連接小組總裁兼首席執行官埃莉諾·加羅-霍爾德說：“出現過敏反應的患者必須有信心，他們的救援藥物將盡快提供足夠的藥物，不會失敗。”
The company's remaining supportive studies, including the self-administration and oral allergy syndrome (OAS) challenge, are underway.
該公司剩餘的支持性研究，包括自我給藥和口腔過敏綜合症（OAS）挑戰，正在進行中。
The self-administration study's dosing is expected to conclude in the second quarter of 2024, and the OAS challenge study's initial dosing is expected to occur in July 2024.
自我給藥研究的給藥預計將於2024年第二季度結束，美洲國家組織挑戰研究的初始給藥預計將於2024年7月進行。
If approved by the FDA, Anaphylm (epinephrine) sublingual film has the potential to be the first and only non-invasive, orally delivered epinephrine for severe life-threatening allergic reactions, including anaphylaxis.
如果獲得美國食品藥品管理局的批准，Anaphylm（腎上腺素）舌下薄膜有可能成爲第一種也是唯一一種非侵入性的口服腎上腺素，用於治療危及生命的嚴重過敏反應，包括過敏反應。
The company remains on track to complete Anaphylm supportive clinical studies and expects to request a pre-NDA meeting with the FDA in the third quarter of 2024.
該公司仍有望完成Anaphylm支持性臨床研究，並預計將在2024年第三季度要求與美國食品藥品管理局舉行保密協議前會議。
Price Action: AQST shares are up 0.26% at $2.44 at the last check on Tuesday.
價格走勢：在週二的最後一次檢查中，AQST股價上漲0.26％，至2.44美元。
Photo by Evan Lorne via Shutterstock
照片由 Evan Lorne 通過 Shutterstock 拍攝