Futura's Fast-Acting Topical Gel for the Treatment of Erectile Dysfunction Granted Marketing Authorisation by the US FDA for Over the Counter Sale

Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology currently focused on sexual health, today announces that the US Food and Drug Administration ("FDA") has granted over the counter sale ("OTC") Marketing Authorisation for MED3000, the Company's breakthrough, topical gel formulation for the treatment of erectile dysfunction ("ED") as a De Novo Medical Device.  

MED3000 can now be legally marketed in the USA as the first topical treatment for ED 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 prevalence of ED disrupts the lives of at least 1 in 5 men globally¹ with around 22 million men suffering ED in the US making the US the largest ED market in the world.

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.  Initial launches commenced under the brand name Eroxon® in March 2023 with further launches planned through 2023 and beyond with commercial agreements in key markets including the European Economic Area, UK, Switzerland, South Korea, Latin America and Middle East.

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."

1.      EMA, Withdrawal assessment report for Viagra, 2008

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014 as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.