- Planned bioequivalence study in healthy adult male subjects will compare the rate and extent of absorption of ASP-001 (Sildenafil Oral Spray) versus Viagra® tablets
- Companion food-effect study will compare rate and extent of absorption of ASP-001 (Sildenafil Oral Spray) under fasted versus fed conditions
ENGLEWOOD CLIFFS, NEW JERSEY – AUGUST 1, 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 it has submitted an Investigational New Drug (IND) application, which has been accepted for review, to the U.S. Food and Drug Administration (FDA) for ASP-001 (Sildenafil Oral Spray) in the treatment of erectile dysfunction. Aspargo plans to commence the clinical studies described in the IND in the fourth quarter of 2023, pending the FDA’s acceptance of the Company’s filing.
Aspargo intends to compare ASP-001 to Viagra® tablets and the effects of ASP-001 administered under fasted and fed conditions in separate but simultaneous single-dose Phase 1 studies in healthy adult male subjects. Among the primary objectives of the studies are 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®.
- Any food effects on the pharmacokinetics of sildenafil and its active metabolite in plasma following a single dose of 100mg of ASP-001.
- The rate and extent of absorption of 100mg of ASP-001 when administered under fed conditions versus fasted conditions.
“We are committed to disrupting the traditional administration of solid oral dosage forms of popular medications in order to achieve greater convenience and resulting compliance across all patient demographics,” commented Michael Demurjian, Chairman and CEO of Aspargo. “Our initial product candidate, Sildenafil Oral Spray, offers a convenient, discreet option for men with erectile dysfunction. Currently, we market Sildenafil Oral Spray in Spain and are preparing for our commercial launches in Germany, other European countries, the UK, and Central and South America. We intend to leverage our learnings from our international launches to optimize our commercial success in the US market. I would like to acknowledge our regulatory, manufacturing and operations team members who have worked diligently for the past two years to prepare and file our IND and achieve this significant FDA milestone.”
Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5mg of sildenafil per push. Aspargo uses a metered-dose container that delivers the precise amount of sildenafil citrate per push based on patient need. The discreet and easy-to-carry oral spray allows the user to customize dosing, with physician direction, and avoid pill splitting or crushing common with the traditional tablet medication.
Erectile dysfunction (“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, Italy1, 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 Spray from Farmalider, S.A. of Madrid, Spain (www.farmalider.com). For additional information, please visit our website at 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, they give 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.
1Rastrelli 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