The study results were published in the International Journal of Science and Research (IJSR). ASP-001 utilizes sildenafil, the active ingredient found in Viagra®, and has already received regulatory approval in various countries such as Spain, Germany, the Netherlands, Ireland, Mexico and the United Kingdom.

研究结果发表在《国际科学与研究杂志》（IJSR）上。ASP-001使用西地那非（伟哥®中的活性成分），并已在西班牙、德国、荷兰、爱尔兰、墨西哥和英国等多个国家获得监管部门的批准。

Aspargo Labs now seeks to obtain its first U.S. Food and Drug Administration (FDA) approval for ASP-001, while also pursuing oral suspensions and solutions for other prescription and over-the-counter medications currently only available in tablet form..

Aspargo实验室目前正在寻求获得美国食品和药物管理局（FDA）对ASP-001的首次批准，同时还寻求口服悬浮液和解决方案，用于目前仅以片剂形式提供的其他处方药和非处方药。。

Aspargo Labs' groundbreaking oral spray formulation of sildenafil presents an alternative to the commonly used tablet form, providing patients with increased discretion and spontaneity. Using its oral suspension technology, the Company aims to tackle key obstacles associated with traditional pills, such as slower absorption rates and the need for fasting or food consumption before administration.

Aspargo Labs开创性的西地那非口服喷雾剂配方替代了常用的片剂形式，为患者提供了更多的自由裁量权和自发性。该公司利用其口服悬浮技术，旨在解决与传统药丸相关的关键障碍，例如吸收速度较慢以及服用前需要禁食或进食。

Additionally, its convenient application method eliminates the need for accompanying liquids. By enhancing convenience and flexibility, Aspargo Labs’s technology represents a patient-centric approach towards improving the efficacy, adherence and safety of medication usage..

此外，其方便的应用方法消除了对伴随液体的需要。通过增强便利性和灵活性，Aspargo实验室的技术代表了一种以患者为中心的方法，旨在提高药物使用的有效性，依从性和安全性。。

“Our innovative oral spray technology has been carefully developed to provide a novel approach for administering medication, simplifying the process of drug consumption,” said Michael Demurjian, CEO of Aspargo Labs. “The study data provides evidence for the safety and pharmacokinetic profile of our oral spray technology.

Aspargo实验室首席执行官迈克尔·德默吉安（MichaelDemurjian）表示：“我们精心开发了创新的口服喷雾技术，为给药提供了一种新颖的方法，简化了药物消耗过程。”。“研究数据为我们的口服喷雾技术的安全性和药代动力学特征提供了证据。

Our research has demonstrated that ASP-001 exhibits rapid absorption, surpassing the absorption rate of Viagra® tablets in the initial minutes after administration. We look forward to collaborating with the FDA to file an NDA for ASP-001 for the treatment of ED under the 505(b)2 regulatory pathway and are enthusiastic about the opportunity to make this drug available to patients in the US.”.

我们的研究表明，ASP-001表现出快速吸收，在给药后的最初几分钟内超过了伟哥®片剂的吸收率。我们期待着与FDA合作，根据505（b）2监管途径为ASP-001治疗ED提交NDA，并对向美国患者提供这种药物的机会充满热情。”。

The recently published IJSR study was authored by Dr. Steven Kaplan, Chief Medical Officer at Aspargo Labs, Director of the Men’s Wellness Program at the Mount Sinai Health System and Professor at the Icahn School of Medicine at Mount Sinai.

最近发表的IJSR研究由史蒂文·卡普兰博士（Steven Kaplan）撰写，他是阿斯帕戈实验室（Aspargo Labs）首席医疗官、西奈山卫生系统（Mount Sinai Health System）男性健康计划主任、西奈山伊坎医学院（Icahn School of Medicine）教授。

“The rapid and enhanced absorption profile demonstrated by ASP-001 in this Phase 1 study highlight its potential to address key unmet needs in the treatment of erectile dysfunction,” said Dr. Kaplan. 'Many patients struggle with the inconvenience and lack of spontaneity associated with planning ahead to take a tablet and the requirement to fast or time their dosing.

卡普兰博士说：“ASP-001在第一阶段研究中显示出快速增强的吸收特征，突显了其在解决勃起功能障碍治疗中未满足的关键需求方面的潜力。”许多患者面临着提前计划服用片剂的不便和缺乏自发性以及快速或定时给药的要求。

An oral spray formulation that achieves therapeutic levels quickly could represent a significant advancement in patient-centric therapy. If approved, ASP-001 would be a welcome addition to the treatment landscape, offering patients and their partners a novel and practical option to enhance their sexual health and overall quality of life.”.

快速达到治疗水平的口服喷雾制剂可以代表以患者为中心的治疗的显着进步。如果获得批准，ASP-001将成为治疗领域的一个受欢迎的补充，为患者及其伴侣提供一个新颖实用的选择，以提高他们的性健康和整体生活质量。”。

The open-label, single center, two-way crossover study examined the pharmacokinetics of 4 ml of ASP-001 versus 100 mg Viagra® in 53 healthy, fasted male volunteers. Additional endpoints include rate and extent of absorption, safety, and tolerability. Patients were selected following a 28-day screening period, then were randomized and checked-in at a Phase 1 clinical trial unit the evening before day-one dosing to ensure at least a 10-hour fasting period.

这项开放标签的单中心双向交叉研究检测了53名健康禁食男性志愿者中4 ml ASP-001与100 mg伟哥®的药代动力学。其他终点包括吸收率和程度，安全性和耐受性。在28天的筛查期后选择患者，然后随机分组，并在第一天给药前一天晚上在1期临床试验单位进行检查，以确保至少10小时的禁食期。

A total of 24 plasma blood samples were collected over 24 hours..

在24小时内共收集了24份血浆样本。。

Key results from the study include:

该研究的主要结果包括：

Initial absorption was observed within 5 minutes of administration, showing a higher average amount in the bloodstream (0.615 ng/mL) compared to Viagra® tablets (0 ng/mL), suggesting that ASP-001 is absorbed more quickly

在给药后5分钟内观察到初始吸收，与伟哥片剂（0 ng/mL）相比，血液中的平均吸收量（0.615 ng/mL）更高，表明ASP-001的吸收更快

Average levels of the medication in the bloodstream via mean plasma concentrations were shown to be higher for ASP-001 as compared to Viagra® tablets during the first 30 minutes after administration by mouth

在口服给药后的前30分钟内，ASP-001的平均血浆药物浓度高于伟哥片剂

The company is advancing additional regulatory submissions to support approvals in key global markets, including Japan and several countries in the Middle East and South America.

该公司正在推进更多的监管提交，以支持关键全球市场的批准，包括日本以及中东和南美的几个国家。

Viagra® is a registered trademark of Viatris Inc.

伟哥®是Viatris Inc.的注册商标。

About Aspargo Laboratories, Inc.

关于Aspargo Laboratories，Inc。

Aspargo Laboratories, Inc., is a commercial stage, specialty pharmaceutical company focused on advancing how drugs are delivered with innovative oral sprays. Aspargo Lab’s innovative oral suspension technology platform has the potential to transform a wide range of medications across various therapeutic areas, with an initial focus on bringing an oral spray formulation of sildenafil to market.

Aspargo Laboratories，Inc.是一家商业化的专业制药公司，专注于推进创新口服喷雾剂的药物输送方式。Aspargo实验室创新的口服悬浮技术平台有可能在各个治疗领域改变多种药物，最初的重点是将西地那非口服喷雾剂配方推向市场。

By converting solid dose medications into convenient, easy-to-administer oral sprays, Aspargo Lab's platform offers several key advantages, including enhanced drug delivery, patient-centricity, dosing flexibility and more personalized medicine. Aspargo is the US and international licensee of the patent rights covering Sildenafil Spray from Farmalider, S.A.

通过将固体剂量药物转换为方便，易于管理的口服喷雾剂，Aspargo实验室的平台提供了几个关键优势，包括增强药物输送，以患者为中心，给药灵活性和更个性化的药物。Aspargo是Farmalider，S.A.西地那非喷雾剂专利权的美国和国际被许可人。