• 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)
  • 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

PROJECT TIMELINE: US FDA 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.