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公司（納斯達克：AQST）發佈了其產品候選物質Anaphylm（腎上腺素）舌下膜的溫度/ pH研究的頂線藥代動力學（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是該公司目前唯一口服注射用腎上腺素前藥的產物，用於治療包括過敏性休克在內的嚴重危及生命的過敏反應。
In March, Aquestive Therapeutics released topline clinical data from its Phase 3 PK study of Anaphylm, meeting all primary and secondary pharmacokinetic endpoints.
今年3月，Aquestive Therapeutics公佈了Anaphylm第3期PK研究的頂線臨床數據，達到了所有的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、通過和離開體內的過程。
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.
這項單劑量的5期隨機交叉試驗旨在比較在正常水、檸檬水和小蘇打水中消耗Anaphylm之後的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PK參數是在30個健康成年人門診服藥後測量的腎上腺素最大濃度（Cmax）和曲線下面積（AUC）以及不同時間點的曝光量。
Topline PK data from the study showed no statistically significant difference in PK results based on changes in temperature and pH.
該研究的頂線PK數據顯示，基於溫度和pH變化的PK結果沒有統計學上顯著的差異。
The most consumed beverages, such as soda, milk, coffee, and juice, have acidity between lemon water and normal water.
最常飲用的飲料，如蘇打水、牛奶、咖啡和果汁，其酸度介於檸檬水和正常水之間。
While not statistically significant, alkaline substances like baking soda showed a somewhat higher absorption level than room-temperature water.
儘管沒有統計學意義，像小蘇打這樣的鹼性物質顯示出了比室溫水稍高的吸收水平。
"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.
“過敏反應患者必須相信他們的救援藥物能夠在最短時間內提供足夠的藥物而無需擔心失效”，食品過敏和過敏反應聯盟（FAACT）的總裁兼首席執行官Eleanor Garrow-Holding說道。
The company's remaining supportive studies, including the self-administration and oral allergy syndrome (OAS) challenge, are underway.
該公司的其他支持性研究（包括自我管理和口腔過敏綜合症（OAS）挑戰研究）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.
自我管理研究的計量預計將於2024年第二季度結束，口腔過敏反應挑戰研究的初始計量預計將在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.
如果該產品獲得FDA批准，Anaphylm（腎上腺素）舌下膜有可能成爲首個、唯一的非侵入性、經口給藥的過敏反應救治藥物。
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.
該公司計劃在完成Anaphylm支持性臨床研究後，於2024年第三季度向FDA提出前新藥申請（pre-NDA）會議申請。
Price Action: AQST shares are up 0.26% at $2.44 at the last check on Tuesday.
截至週二最後查詢，AQST股票上漲0.26％，最新股價爲2.44美元。
Photo by Evan Lorne via Shutterstock
圖片由Shutterstock的Evan Lorne提供。
譯文內容由第三人軟體翻譯。