Futura Medical PLC (AIM:FUM, OTC:FAMDF) said it has secured regulatory approval for its fast-acting gel-based erectile dysfunction treatment, MED3000, in Saudi Arabia.
The product will be launched and marketed by Labatec Pharma as Eroxon in the fourth quarter.
Manufacturing for the launch is complete and will be accompanied by a comprehensive marketing campaign.
"Eroxon is a game changer in the ED space with its rapid speed of onset helping men get an erection within 10 minutes," said chief executive James Barder.
"This approval comes at a pivotal time for the company, as we continue to grow and expand the availability of MED3000 globally by building out our licensing and distribution network."
Saudi Arabia ranks among the top ten global markets for erectile dysfunction treatments, with 10.45% of its married male population reportedly affected.
Labatec will introduce Eroxon at the 20th Urological Association of Asia Congress, starting on 28 September in Dubai.
This approval in Saudi Arabia follows recent launches of Eroxon in Europe and the UK, and the US Food and Drug Administration's endorsement of MED3000 as the first non-prescription gel for erectile dysfunction.
Futura has now gained approval in six Middle Eastern nations, reinforcing its growing presence in the region.
Not only is Eroxon fast acting, but it also avoids many of the side effects associated with blue pill-type ED treatments.