Futura Medical PLC (AIM:FUM, OTC:FAMDF) said it is "firmly focused" on gaining marketing approval for its erectile dysfunction (ED) product in the US, with a decision from the drug regulator expected at some point next quarter.
The green light from the Food and Drug Administration (FDA) would set the scene for the launch of MED3000 as America’s first over-the-counter treatment for ED.
Also known as Eroxon, the topical gel works almost immediately and avoids many of the side effects associated with taking ‘blue pill' treatments.
US sign-off could be transformational, and Futura said it is currently "progressing" commercial discussions there.
“We are also firmly focused on gaining marketing authorisation in the key market of the USA in the near term to enable the marketing of MED3000 as a clinically proven topical treatment for ED with a rapid speed of onset and without the need for a doctor's prescription,” the company said in commentary alongside full-year results.
Futura has primed manufacturers ready for the launch of Eroxon across Europe and the UK and is already selling the product online in these markets.
Turning to the financials, the group said it ended 2022 with just over £4mln in the bank. It will also have access to a research and development credit worth £1.02mln.
Together, they provide a cash runway long enough to see Futura beyond the initial launches of Eroxon and past the approval point by US regulators.
The company posted a total loss for the 12 months ended 31 December 2022 of £5.85mln, of which £4.13mln was spent on R&D.
“We are proud and excited for Eroxon to have now commenced launch for what we believe will become the world's first fast-acting clinically proven topical gel treatment for ED available without the need of a doctor's prescription,” said chief executive James Barder.