Gel treatment for erectile dysfunction gets positive results from clinical trial
Futura Medical has announced positive results from a clinical trial of a topical gel formulation for the treatment of erectile dysfunction (ED).
The results of the confirmatory Phase 3 clinical study, FM71, were announced today (August 31).
MED3000 is a revolutionary, fast-acting gel produced by Futura’s DermaSys transdermal drug delivery technology. It is CE marked in Europe and CA in the UK, which means it has been assessed to meet high safety and environmental protection requirements as a clinically proven topical treatment for adult men with dysfunction. erection helping them get an erection in 10 minutes.
Very positive results
The FM71 results are very positive, consistent with data generated in the previous study and broadly comparable to the results of a recent “real world” home use study.
The data that has already been accumulated shows that MED3000 is an effective treatment option with a rapid onset of action and a favorable risk/benefit profile, ideally suited for over-the-counter (OTC) classification.
The company says it should provide an alternative to existing ED treatments, which require a doctor’s prescription, for patients looking for fewer systemic side effects and a spontaneous intercourse experience. It also provides an important treatment option for patients who currently cannot use current prescription treatments, such as men taking nitrate medications.
Topically applied gel
FM71 is a multicenter, randomized, open-label, home-use, parallel-group clinical study of topically applied MED3000 gel versus tadalafil 5mg oral tablets for the treatment of erectile dysfunction over a 24-week period. The trial design and clinical endpoints have been agreed with the U.S. Food and Drink Administration (FDA) as a confirmatory clinical trial for the U.S. regulatory filing for MED3000, which will continue to target filing by the end of September 2022.
James Barder, CEO of Futura Medical, said, “We are excited to bring a truly differentiated treatment option to the United States for men with erectile dysfunction without the need for a doctor’s prescription. The data generated is another milestone for Futura, as the United States remains the world’s largest market opportunity for erectile dysfunction treatments.
“After several productive and positive pre-submission meetings held with the FDA to discuss the path to OTC status, as well as additional clinical and non-clinical requirements, we hope to achieve prompt and successful regulatory clearance for MED3000 and continue to target US OTC FDA marketing authorization for MED3000 in the first quarter of 2023.
“In the United States, 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 rapid onset speed and creating a new category over-the-counter major for ED treatment.”
Futura 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 erectile dysfunction compared to baseline (pre-treatment). Subjects were recruited from the United States (African Americans), Poland, Georgia, and Bulgaria and included men with organic and psychological erectile dysfunction or a combination of both.
Ken James, Executive Director, added, “The data shows that MED3000 is effective for all ED patient severities and achieves clinically relevant efficacy at all time points up to and including 24 weeks.
“Notably, MED3000 helps men achieve the first signs of an erection within 10 minutes based on pre-determined statistical criteria agreed upon with the FDA. MED3000 has also demonstrated excellent safety compared to oral prescription medications and as such, has a very favorable benefit/risk profile, which makes it well suited for OTC classification in the United States.