Aspargo Laboratories, Inc. announced that it has submitted an Investigational New Drug application, which has been accepted for review, to the U.S. Food and Drug Administration for ASP-001 in the treatment of erectile dysfunction.
- 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, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- 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 https://aspargolabs.com/.
Forward-Looking Statements
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Contact:
Aspargo Laboratories, Inc.
(201) 408-4831
info@aspargolabs.com
1 Rastrelli 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
