Research & Development
Futura Medical Touts Positive Phase 3 Study Results for Erectile Dysfunction Candidate
21 September 2022 - - UK-based pharmaceutical company Futura Medical plc (AIM: FUM) has received positive results from the confirmatory Phase 3 clinical study, "FM71" for MED3000, an investigational therapy for the treatment of erectile dysfunction, the company said.

According to the study results, co-primary endpoints that were agreed to with the US Food and Drug Administration were met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeks.

Secondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication used in the study.

Exploratory endpoints demonstrated MED3000 achieved clinically important improvements in erectile function at all time points and was clinically effective in mild, moderate, and severe ED sufferers.

Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 and overall, with a highly favorable side-effect profile.

Futura is on track to file its dossier with the FDA by the end of September, targeting marketing authorization by the FDA of MED3000 in Q1 2023 as the first major ED treatment available over-the-counter classification I.

MED3000 is CE marked in Europe and CA marked in the UK, as a clinically proven topical treatment for adult men with ED that helps men get an erection within 10 minutes.

FM71 results are highly positive, in line with data generated in the previous Phase 3 clinical study and broadly comparable with results from a recent "real world," home-user study.

Accumulated MED3000 clinical data demonstrates that it may be a treatment option with a rapid onset of action and favorable risk versus benefit profile ideally suited for OTC classification.

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 may provide an important treatment option for those patients who are currently precluded from using current prescription treatments, such as those men taking nitrate medication.

FM71 is a multi-center, randomized, open-label, home use, parallel group, clinical investigation of topically-applied MED3000 gel compared to oral tadalafil tablets for the treatment of ED over a 24-week period.

The trial design and clinical endpoints were agreed to with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000 which the company continues to target filing by the end of September 2022.