Futura Medical plc (AIM: FUM), an innovative pharmaceutical company developing products based on its own transdermal DermaSys® drug delivery technology, is proud to announce that its revolutionary MED3000 topical gel formulation for the treatment of erectile dysfunction (ED) has been granted an Over the Counter (OTC) Marketing Authorization by the US Food and Drug Administration (FDA)! This pioneering product marks a brand new era of accessibility for sufferers of ED, providing an effective, painless and convenient alternative treatment to traditional ED medication.
MED3000 has achieved a major milestone – it is now the first and only topical ED treatment available without a prescription in the United States. Approved as an effective, clinically proven treatment, it provides patients with a much faster onset of action than oral medications like Cialis and Viagra – just 10 minutes. This is a particularly important development for the US, which makes up the largest ED market in the world.
The prevalence of ED disrupts the lives of at least 1 in 5 men globally1 with around 22 million men suffering ED in the US. There has been little innovation in ED treatments for over a decade and many patients continue to suffer dissatisfaction with current therapies and have limited access to safe and effective treatments.
Futura is proud to announce that MED3000 has been approved as the very first pan-European clinically proven topical treatment for ED available OTC and is now available in both Belgium and the UK. Futura has also secured multiple commercial agreements with key markets such as Europe, the UK, Switzerland, South Korea, Latin America and the Middle East. The MED3000 is already rolling out under the brand name Eroxon®, marked by its initial launches in March 2023, and further launches planned throughout 2023 and beyond.
Through its network of powerful licensing and distribution partners with expert knowledge in brand building, pharmaceutical credibility, regional infrastructure and marketing strategies, Futura is continuing to work on establishing and expanding its presence of MED3000 around the world.
The US FDA’s granting of marketing authorisation to Futura Medical for MED3000, the first clinically proven, topical gel for the treatment of ED in the US available without a doctor’s prescription, is a major milestone for us. We successfully met the high standards set by FDA by submitting 22 clinical, biocompatibility, human factors studies and performance bench tests that were rigorously reviewed and accepted. This approval is a major de-risking event for the Company, and we look forward to updating shareholders soon on our US commercialisation plans.
Futura Medical is delighted to announce that it has received a warrant exercise notice from Lombard Odier Asset Management (Europe) Limited (“Lombard Odier”), who have opted to exercise their rights to 10,937,500 Ordinary Shares of 0.2 pence with a exercise price of 40 pence per share, resulting in proceeds of £4,375,000 to the Company.
About Futura Medical plc
Futura Medical plc (AIM: FUM) is a leading pharmaceutical company pioneering the use of its proprietary DermaSys® transdermal technology to develop innovative products. Every DermaSys® formulation is unique, expertly tailored to meet the clinical efficacy, safety and convenience requirements of the selected application and indication. Futura Medical strategically designs its development and commercialisation strategies to ensure that their products offer maximum differentiation and value, all while minimising any risks.
Futura’s MED3000 is a revolutionary treatment for erectile dysfunction that works through an innovative evaporative mode of action. Thanks to two successful Phase 3 studies, FM57 and FM71, it has been granted a CE Mark and US marketing authorisation respectively. MED3000 proves to be an effective and safe solution for ED, with a fast onset and well-balanced benefit-risk profile that made it suitable for an ‘Over the Counter’ classification.
Eroxon® is the answer to the prayers of many men with erectile dysfunction. Powered by clinically-proven effectiveness, this topical treatment offers a safe and dependable remedy that can help you get an erection within 10 minutes! Approved by the FDA in the US, CE marked in Europe and UKCA marked in the UK, the product is raked as an exemplary solution to ED problems. While it goes by the name Eroxon® in certain regions, the Company internally calls it MED3000 to refer to countries where regulatory approval or commercial distribution agreements have not yet been achieved.