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 FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000 which we continue to target filing by the end of September 2022.
FM71 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.
Patients enrolled into the FM71 study for the initial four weeks had to attempt intercourse on at least four occasions in order to establish the severity of their ED known as the ‘baseline’, after which MED3000 was used as per trial protocol for 24 weeks.
Tadalafil was chosen as a control product at the original suggestion of FDA. We agreed with the choice as it represents a widely used marketed product in the USA. After discussion with FDA, they agreed that we could use the lowest effective and approved dose in the USA (5mg). As indicated above, the purpose of including and assessing relative efficacy and safety is to help FDA determine the benefit risk ratio for MED3000 against a marketed control. It is not a pre-requisite for success in the study that we match the efficacy of tadalafil.
Unlike MED3000, oral tadalafil failed to meet the criteria agreed with FDA to demonstrate onset of action within 10 minutes. Oral tablets typically take 30-60 minutes to work.
In September 2022, Futura announced positive results from the confirmatory Phase 3 clinical study, “FM71” for MED3000, for the treatment of erectile dysfunction.
MED3000 presents an effective clinically proven treatment for erectile dysfunction (“ED”) with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for Over the Counter (“OTC”) classification1
Futura filed a dossier with the US FDA in October 2022, targeting marketing authorisation by the FDA of MED3000 in Q2 2023 as the first major ED treatment available OTC throughout the USA.
“Clinically proven gel to treat erectile dysfunction” and “Helps you get an erection within 10 minutes” are the approved EU and UK claims. These claims are subject to ratification by FDA.