• Convenient oral spray administration 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 adverse side effects
  • Advantageous for erectile dysfunction patients suffering from dysphagia (difficulty swallowing) by avoiding the need to crush tablets prior to dosing
  • Farmalíder’s proprietary oral suspension formulation of sildenafil citrate is protected by US patent No. 10,016,428 B2, — Pharmaceutical Composition of Sildenafil Citrate in the Form of a Suspension for Oral Use (expires March 2036)
  • 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

  • The FDA has confirmed to Aspargo that Sildenafil Oral Spray is eligible for FDA approval under the 505 b(2) regulatory approval pathway for new formulations of previously approved drugs
  • 505 (b)(2) allows Aspargo to utilize VIAGRA® safety and efficacy data to demonstrate the safety and efficacy of Sildenafil Oral Spray
  • Aspargo’s route to 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
  • The 505(b)(2) pathway results in millions of dollars in cost savings for Aspargo compared to development of a new drug

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 in Europe and commercially launched in Spain in late 2019 and is awaiting approval in 9 European countries and 8 Latin American countries. The product is going through the registration process in 40 jurisdictions worldwide.

Currently, Sildenafil Oral Spray is approved for sale and marketed in Spain under the brand name, “Bandol”;   near-term commercial launches planned in Portugal, Mexico, Italy, Czech Republic, Slovak Republic, Greece and Australia, additional applications planned for Croatia, France, Germany and Austria.
Sildenafil Oral Spray is approved in Mexico, Nicaragua, Panama, Costa Rica, Honduras, Guatemala, El Salvador and the Dominican Republic.

Licensed by Farmalider to a leading Indian pharmaceutical company for sale in China; product registration process ongoing with planned commercial launch in 2021.

Licensed by Farmalider to a multinational generic pharmaceutical company for OTC sale in Israel; product registration process ongoing with planned commercial launch in 2021.