Futura Medical PLC (LON:FUM) said it expects to have the headline data from its erectile dysfunction drug (ED) by the end of the year after completing dosing for the European phase III clinical trial.
Chief executive James Barder said the release of healding findings from the FM57 study would be a “key value inflection point” for the company.
In the same announcement, the company said recruitment for a one-year, open-label extension study involving 1,000 men had been successfully concluded.
This will assess the long-term safety and tolerability of the gel product and is a standard regulatory requirement for drugs intended for extended treatment of non-life-threatening conditions.
"It is estimated that one in six men will experience some form of ED in their lives,” CEO Barder said.
“We believe MED2005 will offer new hope to ED suffers, in an area that has seen little innovation for nearly two decades and has the potential to be a first line treatment option for ED."
The Futura gel uses the company’s DermaSys technology to direct the active ingredient through the skin.
This means it has a faster onset than the blue pills used for erectile dysfunction, which tend to take up to 20 minutes. And MED2005 is known to avoid some of the side-effects of traditional medication.