Futura Medical, a company developing a portfolio of products based on its transdermal DermaSys drug delivery technology and currently focussed on sexual health and pain, has announced that the EU Notified Body has successfully completed its review of the company’s technical dossier for MED3000 with a recommendation to certificate MED3000 as a Class II b approved medical device.
Once the certificate is received, Futura’s topical gel formulation MED3000, will become the first pan-European topical treatment for erectile dysfunction (“ED”) available without the need of a doctor’s prescription.
As announced previously, Futura had submitted the Technical Dossier for MED3000 for treatment of ED under the European Medical Device Regulation for marketing approval in Europe by an EU Notified Body. European approval for MED3000 will be final upon issuance of a Medical Device Regulation certificate by the panel which is expected before the end of May.
Once EU certification and the resultant CE mark is granted, this paves the way for rapid approval in many countries around the world, in regions including the Middle East, Africa, the Far East and Latin America, who allow “fast-track” review based on their recognition of the EU CE mark. The CE marking will also be recognised in Great Britain until 30 June 2023 and in the period leading up to this the Company will secure the new post-Brexit UKCA mark. This will be a streamlined process since it is understood the UK application can bridge to the EU approval.
Futura continues to progress marketing approval for MED3000 in the USA for use as a non-prescription, clinically proven treatment of ED. With respect to the USA, as announced recently, Futura has had a constructive fourth meeting with the FDA to finalise the clinical trial protocol for the required small supplementary study and is awaiting final meeting minutes.
MED3000 has the potential to be a highly differentiated product by addressing significant unmet needs, across all patient severities in the $5.6 billion global ED market. As such it has the potential to become the first globally available, clinically proven, over the counter treatment for erectile dysfunction.
The prevalence of ED disrupts the lives of at least one in five men globally, with around 23 million men in the US and 20 million men in the UK, France, Italy and Germany.
