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.
Further information can be found in the FM71 study results press release here, and the FM71 study results webcast here