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(Sharecast News) - Pharmaceutical company Futura Medical has received CE marking for its 'MED3000' erectile dysfunction gel, it announced on Friday.
The AIM-traded firm said the "fast acting" topical gel formulation is the first clinically proven, pan-European topical treatment for adult men with erectile dysfunction (ED), available without a doctor's prescription.
It said studies showed MED3000 to be an "extremely effective treatment" for ED, with an "excellent" safety profile.
MED3000 has an evaporative mode of action, which the company said likely stimulates nerve endings in the glans penis to cause an erection.
MED3000 helps men get an erection within 10 minutes, substantially faster than oral tablet phosphodiesterase-5 inhibitors (PDE5i's), with "significant benefits" for spontaneous rather than pre-planned sexual intercourse.
The CE mark approval of MED3000 from the EU notified body paves the way for approval in a number of countries around the world, including in the Middle East, Africa, the Far East and Latin American regions which allow 'fast-track' review based on recognition of the CE mark.
Due to post-Brexit arrangements, the EU CE mark could be used to market the product in Great Britain until 30 June 2023, by which time a specific UKCA mark would need to be obtained.
That, the company said, would be a streamlined process since it is understood the UK application can bridge to the EU approval.
Manufacturing scale-up and commercial discussions were continuing to progress "well", the board reported.
"Today marks a transformational milestone for the company," said chief executive officer James Barder.
"We are excited to be able to offer MED3000 to millions of patients in Europe as the first, clinically proven over-the-counter treatment for erectile dysfunction."
Barder described MED3000 as a "highly differentiated" product, with a rapid speed of onset addressing "significant" unmet needs across all patient severities in the $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 United States and Asia."
At 1300 BST, shares in Futura Medical were up 30.81% at 58.86p.
18 Jun 2018 13:25
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