Phase 1 study published in International Journal of Science and Research shows absorption of ASP-001 within 5 minutes, which is markedly faster than Viagra tablets
ASP-001 is the first investigational product based on Aspargo Lab’s innovative oral spray formulation technology
Aspargo Labs plans to pursue a new drug application (NDA) in the U.S. with the potential to become the first FDA-approved oral spray formulation for ED
NEW YORK – JULY 30, 2024 – Aspargo Laboratories, Inc. (“Aspargo” or the “Company”), a specialty pharmaceutical and MedTech company focused on transforming drug delivery with innovative oral sprays, today announced the release of a Phase 1 study demonstrating that ASP-001, an investigative sildenafil oral spray in development for erectile dysfunction (ED), achieves absorption starting within five minutes, twice as fast as traditional sildenafil tablets. 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. 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.
“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”
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. 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.
“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. 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.”
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.
“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. 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.”
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. A total of 24 plasma blood samples were collected over 24 hours.
Key results from the study include:
- 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
- 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
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.
Viagra® is a registered trademark of Viatris Inc.
About 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. 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. of Madrid, Spain (www.farmalider.com). For additional information, please visit our website at aspargolabs.com
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