In a breakthrough development for men’s sexual health, the US Food and Drug Administration (FDA) has granted over-the-counter (OTC) marketing authorization to Futura Medical’s topical gel, MED3000, a first-of-its-kind treatment for erectile dysfunction (ED). The quick-acting gel formulation, delivered through Futura’s proprietary DermaSys drug delivery technology, starts working within 10 minutes of application, promising an innovative solution for millions of men globally.
Erectile dysfunction, a prevalent condition affecting at least one in five men worldwide, has seen little innovation in treatment over the last decade. Current oral medications like Cialis and Viagra necessitate a doctor’s prescription and typically require a 30-minute advance intake before effectiveness. MED3000, now legally available without a prescription in the US, the world’s largest ED market, aims to address this void.
MED3000 has already been granted approval as the first clinically proven topical treatment for ED available OTC in Europe, with its availability in Belgium and the UK. With a growing network of commercial partnerships across the European Economic Area, UK, Switzerland, South Korea, Latin America, and the Middle East, Futura is set to expand MED3000’s distribution globally. The product was initially launched under the brand name Eroxon in March 2023, with further releases planned throughout the year and beyond.
James Barder, CEO of Futura Medical, welcomed the FDA’s marketing authorization as a “huge milestone” that validates the company’s progress. “FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. 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,” Barder said.
In parallel to FDA approval, Futura Medical announced a significant funding injection of £4,375M, secured through a warrant exercise by Lombard Odier Asset Management (Europe) Limited. These proceeds will support the future commercialization of MED3000.