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.
周二，Aquestive Therapeutics公司（纳斯达克：AQST）发布了其产品候选物质Anaphylm（肾上腺素）舌下膜的温度/ pH研究的顶线药代动力学（PK）数据。
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是该公司目前唯一口服注射用肾上腺素前药的产物，用于治疗包括过敏性休克在内的严重危及生命的过敏反应。
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公布了Anaphylm第3期PK研究的顶线临床数据，达到了所有的主要和次要药代动力学终点。
Pharmacokinetics is the movement of drugs into, through, and out of the body.
药代动力学是药物进入、通过和离开体内的过程。
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.
这项单剂量的5期随机交叉试验旨在比较在正常水、柠檬水和小苏打水中消耗Anaphylm之后的PK和药效学（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参数是在30个健康成年人门诊服药后测量的肾上腺素最大浓度（Cmax）和曲线下面积（AUC）以及不同时间点的曝光量。
Topline PK data from the study showed no statistically significant difference in PK results based on changes in temperature and pH.
该研究的顶线PK数据显示，基于温度和pH变化的PK结果没有统计学上显著的差异。
The most consumed beverages, such as soda, milk, coffee, and juice, have acidity between lemon water and normal water.
最常饮用的饮料，如苏打水、牛奶、咖啡和果汁，其酸度介于柠檬水和正常水之间。
While not statistically significant, alkaline substances like baking soda showed a somewhat higher absorption level than room-temperature water.
尽管没有统计学意义，像小苏打这样的碱性物质显示出了比室温水稍高的吸收水平。
"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.
“过敏反应患者必须相信他们的救援药物能够在最短时间内提供足够的药物而无需担心失效”，食品过敏和过敏反应联盟（FAACT）的总裁兼首席执行官Eleanor Garrow-Holding说道。
The company's remaining supportive studies, including the self-administration and oral allergy syndrome (OAS) challenge, are underway.
该公司的其他支持性研究（包括自我管理和口腔过敏综合症（OAS）挑战研究）正在进行中。
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.
自我管理研究的计量预计将于2024年第二季度结束，口腔过敏反应挑战研究的初始计量预计将在2024年7月进行。
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.
如果该产品获得FDA批准，Anaphylm（肾上腺素）舌下膜有可能成为首个、唯一的非侵入性、经口给药的过敏反应救治药物。
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.
该公司计划在完成Anaphylm支持性临床研究后，于2024年第三季度向FDA提出前新药申请（pre-NDA）会议申请。
Price Action: AQST shares are up 0.26% at $2.44 at the last check on Tuesday.
截至周二最后查询，AQST股票上涨0.26％，最新股价为2.44美元。
Photo by Evan Lorne via Shutterstock
图片由Shutterstock的Evan Lorne提供。