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Futura's topical erection gel recommended for EU approval
19th Mar 2021 12:26
(Sharecast News) - Pharmaceuticals company Futura Medical said on Friday that the relevant EU notified body has completed the review of its technical dossier for 'MED3000', with a recommendation to certificate MED3000 as a class 2B approved medical device.
The AIM-traded firm said once the certificate was received, its MED3000 topical gel formulation would become the first pan-European topical treatment for erectile dysfunction, available without a doctor's prescription.
Once EU certification and the resultant CE-mark is granted, the board said it would be able to seek "rapid approval" in a number of countries around the world, in regions including the Middle East, Africa, the Far East and Latin America, where 'fast-track' review was permitted based on recognition of the CE mark.
The CE marking would also be recognised in the United Kingdom market until 30 June, and in the period leading up to that, the company said it would secure the new post-Brexit UKCA mark.
That would also be a streamlined process, as it was understood the UK application could bridge to the EU approval.
"The recommendation to approve MED3000 in Europe is a huge milestone for Futura in the development of MED3000," said chief executive officer James Barder.
"We look forward with excitement to bringing MED3000 to patients in Europe as the first, clinically proven treatment for erectile dysfunction that is highly differentiated with its rapid speed of onset.
"Once the certificate is issued, MED3000 may be marketed throughout the EU without the need of a doctor's prescription subject to any national marketing restrictions."
At the close on Friday, shares in Futura Medical were up 172.22% at 49p.
The AIM-traded firm said once the certificate was received, its MED3000 topical gel formulation would become the first pan-European topical treatment for erectile dysfunction, available without a doctor's prescription.
Once EU certification and the resultant CE-mark is granted, the board said it would be able to seek "rapid approval" in a number of countries around the world, in regions including the Middle East, Africa, the Far East and Latin America, where 'fast-track' review was permitted based on recognition of the CE mark.
The CE marking would also be recognised in the United Kingdom market until 30 June, and in the period leading up to that, the company said it would secure the new post-Brexit UKCA mark.
That would also be a streamlined process, as it was understood the UK application could bridge to the EU approval.
"The recommendation to approve MED3000 in Europe is a huge milestone for Futura in the development of MED3000," said chief executive officer James Barder.
"We look forward with excitement to bringing MED3000 to patients in Europe as the first, clinically proven treatment for erectile dysfunction that is highly differentiated with its rapid speed of onset.
"Once the certificate is issued, MED3000 may be marketed throughout the EU without the need of a doctor's prescription subject to any national marketing restrictions."
At the close on Friday, shares in Futura Medical were up 172.22% at 49p.