Futura Medical PLC (AIM:FUM, OTC:FAMDF) believes its MED3000 gel is ideally suited to becoming America’s first over-the-counter treatment for erectile dysfunction (ED) after successfully negotiating a US phase III clinical trial.
It hopes to submit a dossier to the Food & Drug Administration (FDA) by the end of next month targeting marketing approval for the product by the first quarter of next year.
This was after MED3000 achieved its primary goal of improving erectile function and its secondary target of working within 10 minutes of use.
What stood out in the study, which compared Futura’s discovery with a traditional ED drug, was the MED3000’s safety and tolerability profile.
Specifically, there were no serious adverse events. In fact, the treatment had a "highly favourable side-effect profile", investors were told.
Pills such as Viagra and Cialis can sometimes induce unwanted symptoms such as headaches and dizziness meaning that a proportion of the male population can’t use them, while they can also take 30-60 minutes to work.
"We are excited at the prospect of bringing a truly differentiated treatment option for men in the USA with ED without the need for a doctor's prescription,” said Futura chief executive James Barder.