In September 2022, Futura announced positive results from the confirmatory Phase 3 clinical study, “FM71” for MED3000, for the treatment of erectile dysfunction.
- FDA agreed co-primary endpoints 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 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 favourable side-effect profile
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.
Further information can be found in the FM71 study results press release here, and the FM71 study results webcast here