Sildenafil spray approved for erectile dysfunction in Germany, Ireland, and the Netherlands

The German Federal Institute for Drugs and Medical Devices has granted regulatory approval to market Sildenafil oral spray (trade name, Hezkue) for erectile dysfunction (ED) in Germany. The spray was also recently approved for marketability in Ireland and the Netherlands, according to a news release from Aspargo Laboratories, the developer of the treatment.¹

The German market is the largest in the EU, and the aggregate erectile dysfunction market for Germany, Ireland, and the Netherlands exceeds $175 million.

“These product approvals reflect Aspargo’s commitment to quickly expand its global platform to the EU during 2023. The Marketing Authorizations are an important achievement. They validate Aspargo’s international regulatory strategy and confirm that Aspargo meets the highest standards required to ensure the safe distribution of sildenafil spray,” said Michael Demurjian, Chairman and Chief Executive Officer of Aspargo.

Hezkue 12.5mg per actuation, oral suspension was developed by the specialty pharmaceutical group Aspargo Laboratories Inc. in partnership with their commercialization consultant, Syneos Health. The 2 groups held focus groups and conducted surveys with physicians, pharmacists, and patients throughout the development process.

The spray is a liquid suspension of sildenafil citrate administered orally via a spray pump. Aspargo uses a metered-dose pump so that it can deliver the precise, customized dose per push based on the needs of the patient. According to Aspargo, Sildenafil spray is also discreet, easy to carry, and allows patients to avoid crushing or splitting pills with the traditional tablet medications currently available for ED.

Aspargo Laboratories is currently seeking FDA approval to market Sildenafil spray in the United States.

Reference

1. Aspargo receives regulatory approval to market sildenafil spray in Germany, Ireland, and the Netherlands. Aspargo Laboratories Inc. News release. Published online January 24, 2023. Accessed January 25, 2023. https://www.globenewswire.com/news-release/2023/01/24/2594140/0/en/Aspargo-Receives-Regulatory-Approval-to-Market-Sildenafil-Spray-in-Germany-Ireland-and-The-Netherlands.html