- Dosing complete for 53 subjects in Sildenafil Oral Suspension Bioavailability Study
- Initiated dosing in 38 subjects in Sildenafil Oral Suspension Food-Effect Study
- Top-line data from both studies expected in February 2024
ENGLEWOOD CLIFFS, NEW JERSEY – DECEMBER 5, 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 the completion of dosing of all 53 subjects in two cohorts 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”).
In addition, today the Company announced the initiation of dosing of 38 subjects in two cohorts in the Company’s food effect study, comparing the amount of active drug in plasma after administration of a single oral dose of Sildenafil Oral Suspension (ASP-001) under fasting and fed (following a meal) conditions. The open label, single center, single dose, two-way crossover study in healthy subjects, entitled, “A Phase 1 Food-Effect Study of 100 mg of ASP-001 (Oral Liquid Suspension of Sildenafil-Spray) Under Fed Versus 100 mg of ASP-001 (Oral Liquid Suspension of Sildenafil-Spray) Under Fasted Conditions in Healthy Adult Male Subjects”, is assessing any food effects and the rate and extent of absorption of Sildenafil Oral Suspension when administered under fed and fasted conditions.
“We are thrilled about the progress we have made in our clinical trials for Sildenafil Oral Suspension,” said Michael Demurjian, CEO and Chairman of Aspargo Laboratories Inc. “Our goal is to provide patients suffering from ED with a paradigm shifting dosing technique to facilitate positive therapeutic outcomes, and these milestones bring us one step closer to achieving that goal. We look forward to providing top-line data from both studies in early 2024.”
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, 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 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.
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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