Sildenafil oral spray achieves faster absorption vs sildenafil tablets

Findings from a recent phase 1 trial show that ASP-001, an investigational sildenafil oral spray for patients with erectile dysfunction, achieved therapeutic levels at a significantly faster rate compared with traditional sildenafil citrate tablets (Viagra), announced Aspargo Labs, the developer of the formulation, in a news release.¹

Data from the phase 1 study showed that ASP-001 achieved initial absorption within 5 minutes of administration.

“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 Steven Kaplan, MD, Chief Medical Officer at Aspargo Labs, director of the Men’s Wellness Program at the Mount Sinai Health System, and a professor at the Icahn School of Medicine at Mount Sinai.¹ “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.”

Overall, data from the phase 1 study showed that ASP-001 achieved initial absorption within 5 minutes of administration. At this time point, the average amount of medication in the bloodstream was 0.615 ng/mL with ASP-001, vs 0 ng/mL with sildenafil tablets. The average level of medication in the bloodstream via mean plasma concentrations remained higher for those who received ASP-001 vs those who received sildenafil tablets for the first 30 minutes following administration.

In total, the open-label, single center, 2-way crossover study included 53 healthy, fasted male volunteers. Participants were randomly assigned to receive either 4 mL of ASP-001 or to 100 mg sildenafil tablets. All those included in the trial participated in at least a 10-hour fasting period and underwent a total of 24 plasma blood samples over 24 hours.

In addition to the current phase 1 study, ASP-001 is also being assessed in a companion food-effect trial to compare the amount of active drug in participants’ plasma following an administration of the medication under both fed and fasted conditions.² In total, the study plans to enroll 38 participants.

Sildenafil oral spray is currently approved in Spain, Germany, the Netherlands, Ireland, Mexico and the United Kingdom. Aspargo now plans to file a new drug application with the FDA to support regulatory approval of ASP-001 in the United States. Aspargo is also working on regulatory submissions to support approval of ASP-001 in Japan as well as several countries in the Middle East and South America.

“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, in the news release.¹ “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.”

Reference

1. Aspargo Labs announces data on first oral spray for erectile dysfunction, ASP-001, showing two times faster absorption compared to Viagra tablets. News release. Aspargo Labs. July 2024. Accessed August 2, 2024. https://aspargolabs.com/investor/aspargo-labs-announces-data-on-first-oral-spray-for-erectile-dysfunction-asp-001-showing-two-times-faster-absorption-compared-to-viagra-tablets/

2. Aspargo announces completion of dosing of all subjects in sildenafil oral suspension bioavailability study and initiation of dosing in companion food-effect study. News release. Aspargo Labs. December 2023. Accessed August 2, 2024. https://aspargolabs.com/investor/aspargo-announces-completion-of-dosing-of-all-subjects-in-sildenafil-oral-suspension-bioavailability-study-and-initiation-of-dosing-in-companion-food-effect-study/