FDA Grants marketing authorization to newTopical gel for ED
The US Food and drug administration has has granted over-the-counter marketing authorization to first nonprescription topical gel Eroxon for treatment of erectile dysfunction (ED).
MED3000 can now be legally marketed in the USA as the first topical treatment available OTC without the need for a prescription. MED3000 is approved as an effective, clinically proven treatment for ED with a 10-minute onset of action. Oral medications (“PDE5i’s”) such as Cialis and Viagra require a doctor’s prescription in the USA and typically are required to be taken at least 30 minutes in advance. The US represents 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.
MED3000 has already been approved as the first pan-European clinically proven topical treatment for ED available OTC and is now available in Belgium and the UK. With multiple commercial agreements in key markets including the European Economic Area, UK, Switzerland, South Korea, Latin America and Middle East. Futura continues to establish and expand a network of licensing and distribution partners with strength in brand building, pharmaceutical credibility, regional infrastructure and marketing expertise for long-term distribution of MED3000 across the globe. Initial launches commenced under the brand name Eroxon® in March 2023 with further launches planned through 2023 and beyond.
James Barder, Chief Executive Officer of Futura Medical said: “The granting of marketing authorisation by the US FDA as the first clinically proven, topical gel for the treatment of ED in the USA available without a doctor’s prescription is a huge milestone for Futura and highlights the incredible progress that the Company continues to make. 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. 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.”
Futura Medical also announced that it received a warrant exercise notice from Lombard Odier Asset Management (Europe) Limited (“Lombard Odier”) in respect of 10,937,500 ordinary shares of 0.2 pence in the Company ("Ordinary Shares"), with an exercise price of 40 pence per share. Proceeds of £4,375,000 will be received by the Company in respect of the warrant exercise.
