In a significant milestone for UK-based Futura Medical PLC (AIM:FUM, OTC:FAMDF) and a first for the US, the Food and Drug Administration (FDA) has approved the over-the-counter marketing of the company's innovative topical gel for erectile dysfunction (ED).
MED3000 can now be sold without prescription, paving the way for the topical ED treatment to become available on the shelves of American pharmacies.
Boasting a rapid 10-minute onset of action, the product stands apart from prescription-dependent oral medications such as Cialis and Viagra, which typically require at least 30 minutes to take effect. The Futura gel also avoids some common side effects suffered by 'blue pill' users.
With ED impacting at least one in five men globally and 22 million men in the US alone, the demand for accessible treatment is high. This FDA approval allows Futura Medical to tap into the largest ED market worldwide.
MED3000 was the first OTC clinically-proven topical ED treatment across Europe and is currently available in Belgium and the UK.
Trading under the brand name Eroxon since March 2023, Futura has planned further roll-outs throughout the year, having established commercial partnerships in several key markets, including the European Economic Area, the UK, Switzerland, South Korea, Latin America and the Middle East.
Chief executive James Barder called the US sign-off a "huge milestone". "The FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices," he added.
"I am delighted that we met this standard with MED3000's submission of 22 clinical, biocompatibility, human factors studies and performance bench tests which were rigorously reviewed and accepted by the FDA.
"The FDA approval is a major de-risking event for the company and we look forward to updating shareholders on our US commercialisation plans in due course."