Futura Medical plc, a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys drug delivery technology, has announced its progress on regulatory processes and commercial activities for MED3000.
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Futura provides regulatory and commercial update for MED3000
MED3000 is the company’s breakthrough, topical gel formulation for treatment of erectile dysfunction (ED) and Futura is seeking marketing approval for the product in Europe and the US for use as a clinical treatment without the need of a doctor’s prescription.
Further to the Company’s update on 16 September, Futura has continued to work proactively with the FDA to confirm the design of the requested supplemental clinical trial to provide the necessary reassurance of MED3000's efficacy for up to six months.
The Company has confirmed that following its third pre-submission meeting with FDA, there was preliminary agreement on the design and scope of this small supplementary study. The final study protocol can only be completed once the FDA minutes have been received.
Detailed planning for the study has now commenced and Futura is targeting Q1 2021 patient enrolment depending on completion of the final study protocol for FM71.
Futura announced in mid-July that it had submitted the product dossier for MED3000 for treatment of ED under the European Medical Device Regulation for marketing approval as a Class 2B medical device. The EU approval process continues to progress well, the company reported.
In parallel with the regulatory processes, Futura has been working with retained specialised corporate advisers on active commercial discussions with potential licensing and marketing partners. The Company has reasonable expectations that these discussions will be satisfactorily concluded.
James Barder, Chief Executive of Futura Medical, said: “We are happy to see continuing, positive regulatory progress for MED3000 in parallel with advancing commercial discussions and the board is hopeful of signing at least one agreement with a third party. We are increasingly excited at the prospects of bringing to market the first over the counter, topically applied clinically proven treatment for erectile dysfunction with a faster onset of action and enhanced safety profile compared to currently available oral, on demand, drug treatments.”