Futura Medical PLC (AIM:FUM) said the first patient has been recruited for a confirmatory trial of its fast-acting gel for erectile dysfunction (ED) supporting the regulatory submission for the product in the US.
The pharma group said the FM71 evaluation of Futura’s MED3000 and the non-clinical human factors study are now progressing in parallel with completion expected in the second quarter of next year.
The company added it remains on track to apply for approval of the gel as a medical device that can be sold over-the-counter in the US the following quarter. Formal regulatory sign-off is expected in the first quarter of 2023.
Chief executive James Barder said: "We are pleased to announce the first patient visit in our FM71 study with MED3000 with timing as previously indicated.
“This is an important milestone for Futura, as the USA remains the largest market opportunity globally for ED treatments and we are making steady progress towards completing the regulatory submission for MED3000 in the region.
“We are excited by the prospect of bringing a truly differentiated treatment option to US ED sufferers without the need for a doctor's prescription."