- Study will compare bioavailability of Sildenafil Oral Suspension and Viagra® tablets under fasted conditions
- Companion study will evaluate the effects of food on the bioavailability of Sildenafil Oral Suspension
- Studies represent pivotal clinical program to support U.S. New Drug Application
ENGLEWOOD CLIFFS, NEW JERSEY – SEPTEMBER 19, 2023 – Aspargo Laboratories, Inc. (“Aspargo” or the “Company”), a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that all 47 subjects have received their initial dose in the Company’s comparative bioavailability study comparing Sildenafil Oral Suspension (ASP-001) to Viagra®.
The open label, single center, single dose, two-way crossover comparative bioavailability study in healthy subjects, entitled, “A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 mg of ASP-001 (Oral Liquid Suspension of Sildenafil-Spray) versus 100 mg of Viagra® (Sildenafil) Film-Coated Tablets under Fasted Conditions in Healthy Adult Male Subjects”, is assessing the rate and extent of absorption of ASP-001 (Sildenafil Oral Suspension) compared to Viagra® tablets for the treatment of erectile dysfunction (“ED”). A companion food-effect study will assess the rate and extent of absorption of ASP-001 under fasted versus fed conditions. The companion food-effect study will commence next month.
As recommended by the U.S. Food and Drug Administration (FDA)1, the bioavailability study is designed to compare ASP-001 with Viagra® tablets in normal healthy subjects between the ages of 18–55 years. Cliantha Research, Aspargo’s designated clinical contract research organization, is conducting the “crossover” study in 47 volunteers. Each subject is receiving ASP-001 and Viagra® in an alternate fashion over two periods separated by a washout period of six days’ duration. The 47 subjects that completed initial dosing were randomly assigned to receive either a single dose of 100 mg of ASP-001 or 100 mg of Viagra®, with approximately the same number of subjects receiving each treatment. Thus, in the 47 subjects that were dosed in period one, one group received a single dose of ASP-001 and will receive a single dose of Viagra® in period two following the washout period, and the second group received a single dose of Viagra® and will receive a single dose of ASP-001 in period two following the washout period.
Among the primary objectives of the comparative bioavailability study is to determine:
- The pharmacokinetics of sildenafil and its active metabolite in plasma following a single dose of 100mg of ASP-001 as compared to a single dose of 100mg of Viagra®, including the rate and extent of absorption of 100mg of ASP-001 compared to the rate and extent of absorption of 100mg of Viagra®.
- Whether the absorption rate of ASP-001 is superior to the absorption rate of Viagra®.
Assuming favorable outcomes and subject to discussions with the FDA, the Company expects these studies to support the regulatory approval of ASP-001 in the United States without the need for additional efficacy studies.
“Completion of initial dosing of all 47 subjects in this important study represents a significant milestone in our late-stage development program of Sildenafil Oral Suspension for the treatment of ED,” said Michael Demurjian, Chief Executive Officer and Chairman of Aspargo. “This milestone paves the way for us to develop a broad pipeline of products designed to leverage the ease, convenience and efficiency of oral suspension formulations that bypass the breakdown step in the stomach and small intestine necessary for tablet dosage forms, leading to potentially faster delivery of the active ingredient into the bloodstream. We look forward to completing this comparative bioavailability study and initiating our companion food-effect study shortly and sharing results from both studies later this year.”
Sildenafil Oral Suspension is an oral liquid suspension of sildenafil citrate administered via a metered-dose pump that dispenses 12.5 mg of sildenafil per actuation. Aspargo uses a metered-dose container that delivers the precise amount of sildenafil citrate per actuation based on patient need. The discreet and easy-to-carry oral formulation allows the user to customize dosing, with physician direction, and avoid pill splitting or crushing common with the traditional tablet medication.
ED is characterized by the persistent difficulty achieving and maintaining an erection sufficient to have sexual intercourse. While the prevalence of ED has been shown to increase with age, a study conducted by the Sexual Medicine and Andrology Unit at the University of Florence, Italy2, showed that ED in younger men is likely to be overlooked and dismissed without a proper medical assessment, indicating a continued unmet medical need, and demand for new and innovative routes of administration of ED therapeutic products.
About Aspargo Laboratories, Inc.
Aspargo Laboratories, Inc., located in Englewood Cliffs, New Jersey, is a commercial stage, specialty pharmaceutical company. Aspargo’s current focus is to commercialize an oral spray formulation of sildenafil citrate, the active ingredient in Viagra®. Aspargo is the US and international licensee of the patent rights covering Sildenafil Oral Suspension from Farmalider, S.A. of Madrid, Spain (www.farmalider.com). For additional information, please visit our website at https://aspargolabs.com/.
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, management gives no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; and the outcome of pending or future litigation or arbitration.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.
Aspargo Laboratories, Inc.
1Food and Drug Administration (FDA). Guidance for industry: Statistical Procedures for Bioequivalence Studies Using a Standard Two-treatment Crossover Design. U.S Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER). July 1992. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance
2Rastrelli G, Maggi M. Erectile dysfunction in fit and healthy young men: psychological or pathological? Transl Androl Urol. 2017 Feb;6(1):79-90. doi: 10.21037/tau.2016.09.06. PMID: 28217453; PMCID: PMC5313296