Futura Medical has announced positive results from a clinical trial looking into MED3000, a topical gel formulation for the treatment of erectile dysfunction (ED).
The results, from the confirmatory phase 3 clinical study, FM71, were announced today (August 31).
MED3000 is a breakthrough, fast-acting gel produced by Futura Medical’s transdermal DermaSys drug delivery technology. It is CE marked in Europe and CA marked in the UK, signifying it has been assessed to meet high safety and environmental protection requirements as a clinically proven topical treatment for adult men with ED helping them get an erection within 10 minutes.
Highly positive results
FM71 results are highly positive, in line with data generated in the previous study and broadly comparable with results from a recent ‘real world’, home use study.
Data that has already been accumulated shows MED3000 is an effective treatment option with a rapid onset of action and a favorable risk versus benefit profile ideally suited for over the counter (OTC) classification.
The company says it is expected to provide an alternative to existing ED treatments, that require a doctor’s prescription, for those patients seeking fewer systemic side-effects, and a spontaneous intercourse experience. It also provides an important treatment option for those patients who are currently precluded from using current prescription treatments such as those men taking nitrate medication.
Topically applied MED3000 gel
FM71 is a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of topically applied MED3000 gel compared to oral tadalafil 5mg tablets for the treatment of ED over a 24-week period. The trial design and clinical endpoints were agreed with the U.S Food and Drink Administration (FDA) as a confirmatory clinical trial for the US regulatory dossier for MED3000 which will be continued to target filing by the end of September 2022.
James Barder, chief executive officer, Futura Medical said: “We are excited at the prospect of bringing a truly differentiated treatment option for men in the USA with ED without the need for a doctor’s prescription. The data generated is another important milestone for Futura, as the USA remains the largest market opportunity globally for ED treatments.
“Following multiple productive and positive pre-submission meetings held with the FDA to discuss the pathway to OTC status, as well as the additional clinical and non-clinical requirements, we hope to achieve a fast and successful regulatory clearance for MED3000 and continue to target US OTC FDA marketing authorization for MED3000 in Q1 2023.
“In the USA all clinically proven oral ED therapies are prescription-only and therefore MED3000 has the potential to be a significant innovation with its key differentiator of a rapid speed of onset and by creating a major new OTC category for ED treatment.”
Recruitment
Futura Medical said the trial investigated the efficacy and safety of MED3000 gel in 96 male patients clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment). Subjects were recruited from United States (African Americans), Poland, Georgia and Bulgaria and included men who had organic and psychological ED or a combination of both.
Ken James, executive director added: “Data shows that MED3000 is effective across all ED patient severities and achieves clinically important efficacy at each time point up to and including 24 weeks.
“Notably, MED3000 helps men achieve first signs of an erection within 10 minutes according to pre-determined statistical criteria agreed with the FDA. MED3000 has also demonstrated excellent safety in comparison with prescription oral medication and as such has a very favorable benefit to risk profile making it ideally suited to OTC classification throughout the USA.”