Aspargo Labs Inc.
Sildenafil Oral Spray
Proven Technology, Market Exclusivity And IP Protection
Aspargo Laboratories, Inc. is seeking FDA approval to market in the United States a patented oral spray formulation of sildenafil citrate, the active ingredient in VIAGRA®, to treat erectile dysfunction. Our current international focus is to obtain approval in Germany, the largest European market, as a prescription drug, and in the United Kingdom, where VIAGRA® tablets are available “over-the-counter” in the 25mg and 50mg dosage forms. Aspargo’s proprietary drug formulation is protected by granted U.S. and European patents that expire in 2036.
BENEFITS
- Convenient oral spray administration delivered in a discreet easy-to-carry container with no need for accompanying liquids
- Metered pump delivers exactly 12.5 mg per push of the pump to facilitate appropriate dose titration based on patient needs, delivering maximum benefit without the need to crush pills prior to administration
- Readily available and convenient administration for erectile dysfunction patients suffering from dysphagia (difficulty swallowing)
Market Exclusivity & IP Protection
Aspargo has licensed the exclusive rights to commercialize Sildenafil Oral Spray in the United States and more than 30 countries throughout Europe, the United Kingdom, the Middle East, Asia, Canada, South America and Russia from Farmalíder, S.A. (Madrid, Spain), a leader in the Spanish OTC and ibuprofen market.
- Aspargo’s proprietary oral suspension formulation of sildenafil citrate is protected by US Patent No. 10,016,428 B2 (granted: July 10, 2018); European Patent No. EP3072515 (granted: February 28, 2018); and Russian Patent No. RU2016127223A (granted: April 4, 2018) entitled, Pharmaceutical Composition of Sildenafil Citrate in the Form of a Suspension for Oral Use
- Sildenafil Oral Spray market exclusivity also is protected by trade secrets and manufacturing know-how necessary to manufacture the drug product without compromising drug stability or efficacy
- Aspargo is protecting its custom designed spray bottle with US and international patent applications
US Approval Under Section 505(B)(2)
Aspargo is seeking FDA approval for Sildenafil Oral Spray under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which provides that new dosage forms and new routes of administration for a previously approved drug qualify for an expedited form of regulatory approval.
- Aspargo’s route to US approval requires a small, low-risk clinical trial in healthy volunteers, resulting in reduced cost and timeline compared to the traditional clinical trials required for FDA approval of new drugs
- European Approval under “Decentralized Procedure”; Aspargo is leveraging data submitted for existing Spanish approval, including Spanish clinical study results, to obtain approval swiftly in other EU countries through the “Decentralized Procedure” whereby an authorization of a medicine in one European Union Member State is recognized simultaneously by other Member States
Sildenafil Oral Spray, distributed and marketed in Spain on behalf of Farmalider by Laboratorios Rubio under the trade name, “Bandol”, is prescribed by Spanish physicians to treat erectile dysfunction as an alternative to VIAGRA® and Cialis® tablets. The technology was approved by the Spanish regulatory authorities and commercially launched in Spain in late 2019.
- Sildenafil Oral Spray is approved for sale in Spain and is undergoing registration in France and Italy; Aspargo is leveraging the Spanish approval to obtain approval for the spray dosage form in the UK, Germany, other EU Member States and the Middle East without additional clinical studies.
- Aspargo’s international license grants Aspargo exclusive commercialization rights for Sildenafil Oral Spray in more than 30 countries throughout Europe, the United Kingdom, the Middle East, Asia, Canada, South America and Russia. Aspargo is seeking regulatory approval in the UK and Germany, two leading European markets for ED medications. Viagra is classified as a non-prescription medicine in the United Kingdom, making that country the first where the drug can be bought over the counter, meaning it can be sold without a prescription after a discussion with a pharmacist.
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Aspargo Laboratories, Inc. is a clinical-stage biopharmaceutical company developing patient-focused solutions and must-have medicines by combining our innovative science and technologies with FDA’s 505(b)(2) approval pathway and corresponding regulations in international jurisdictions to enhance currently marketed drugs with well-known pharmacology profiles.