Aspargo Laboratories, Inc. announced today that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate bioequivalence and food-effect clinical studies of ASP-001 (Sildenafil Oral Spray) in comparison to Viagra® for the treatment of erectile dysfunction (“ED”).
- Company plans to initiate clinical trials in September 2023 to compare Sildenafil Oral Spray to Viagra® tablets, and effect of dose administration under fasted versus fed conditions
- Represents Aspargo’s first program to receive IND clearance
ENGLEWOOD CLIFFS, N.J., Sept. 05, 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 received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate bioequivalence and food-effect clinical studies of ASP-001 (Sildenafil Oral Spray) in comparison to Viagra® for the treatment of erectile dysfunction (“ED”).
“We are thrilled to have received IND clearance from the FDA for Sildenafil Oral Spray for the treatment of ED. This significant milestone brings us one step closer to introducing in the US a disruptive and paradigm-shifting route of administration for this popular medication,” said Michael Demurjian, Chief Executive Officer of Aspargo. “This program marks our first IND clearance as a company and is a testament to Dr. Rober Niecestro, head of regulatory affairs at Aspargo, and the formulation optimization and CMC data provided by our contract manufacturer, Pharmaceutics International Inc. (“Pii”) and regulatory data developed by our regulatory teams at Pii, QARA and Propharma, which support ASP-001 and our IND submission. We look forward to launching our clinical studies designed to compare Sildenafil Oral Spray to Viagra® tablets later this month through our contract research organization, Cliantha Research, at Cliantha’s Mississauga, Ontario clinic.”
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 actuation based on patient need. The discreet and easy-to-carry oral spray allows for physician prescribed customized dosing and avoids splitting or crushing pills, which is common with the traditional tablet medication.
Erectile dysfunction 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 exclusive licensee of the patent rights covering Sildenafil Spray for the US and many international markets from Farmalider, S.A. (www.farmalider.com). For additional information, please visit our website at aspargolabs.com.
FORWARD-LOOKING STATEMENTS
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.
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Contact:
Aspargo Laboratories, Inc.
(201) 408-4831
info@aspargolabs.com
1 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
