Futura Medical PLC (LON:FUM) said it has now received its CE mark approval for its MED3000 gel formulation as a Class 2B approved medical device.
Futura's fast-acting topical gel formulation MED3000 is the first clinically proven, pan-European topical treatment for adult men with erectile dysfunction (ED) available without a doctor's prescription, Futura said in its stock market announcement.
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The CE mark approval of MED3000 from the EU Notified Body paves the way for approval in many countries around the world, including in the Middle East, Africa, the Far East and Latin American regions that allow "fast-track" review based on recognition of the EU CE mark.
Due to post-Brexit arrangements, the EU CE mark can be used to market the product in Great Britain until 30 June 2023 by which time a specific UKCA mark has to be obtained. This will be a streamlined process since it is understood the UK application can bridge to the EU approval, Futura explained.
Manufacturing scale-up and commercial discussions continue to progress well, the company added.
"Today marks a transformational milestone for the company. We are excited to be able to offer MED3000 to millions of patients in Europe as the first, clinically proven OTC [over the counter] treatment for erectile dysfunction,” said James Barder, the chief executive of Futura Medical.
“MED3000 is a highly differentiated product, with a rapid speed of onset addressing significant unmet needs, across all patient severities in the US$5.6bn global ED market. We look forward to further MED3000 marketing approvals in the coming years in multiple regions across the world, including the USA and Asia," Barder said.