Application to the US FDA for MED3000Source: RNS
3 October 2022
Futura Medical plc
("Futura" or the "Company")
Futura Announces Completion of its De Novo Medical Device Application to the US FDA for its Breakthrough Topical Gel Formulation MED3000 for Erectile Dysfunction
Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today announced that it has now completed all of the work that it believes is required for the FDA to grant marketing authorisation for MED3000, its fast acting clinically proven treatment for erectile dysfunction (ED). The dossier will now be submitted to the FDA and the Company remains confident of being granted marketing authorisation by the FDA by the end of Q1 2023 in line with previously announced timelines. This follows the April 2021 approval of MED3000 CE Mark as the first clinically proven, pan-European (including UK) topical treatment for adult men with ED that will be available without a doctor's prescription.
The FDA submission closely follows FDA guidance on De Novo applications, and guidance received from FDA CDRH in five pre-submission meetings held with the Company. This includes a Human Factors study supporting Over-The-Counter (OTC) designation and two phase 3 clinical studies with MED3000 for the treatment of mild, moderate and severe ED; FM57 clinical trial used for approval in Europe, and the recently announced results from the FDA agreed pivotal Phase 3 clinical study, FM71 which successfully met all primary and secondary endpoints. The results demonstrate that MED3000 presents an effective clinically proven treatment for ED with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for OTC classification in the US.
Subject to FDA granting Marketing Authorisation, MED3000 will become the first major ED treatment available OTC throughout the USA.
Futura continues to strengthen its wide network of licensing and distribution partners across the globe and has recently announced the search for US commercial partners has commenced following the successful completion of FM71 and the completion of the FDA submission which represent a major value inflection point.
James Barder, Chief Executive Officer, Futura Medical said: "Today marks a pivotal milestone for Futura and highlights the regulatory progress we have made to develop and launch MED3000 globally. The submission of our marketing application in the US will pave the way for commercialisation of MED3000 in the biggest ED market worldwide with our key differentiator of a clinically proven treatment for ED with a rapid speed of onset. MED3000 is also expected to be the first major ED treatment available OTC in the USA which we believe will help improve access as well as treatment for many thousands of ED sufferers. We believe Eroxon, the brand for MED3000, is poised to become a major, trusted brand and treatment in the ED market worldwide."
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
Phil Walker/ Richard Lindley/ Ben Cryer/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile/ Zoe Bolt
Tel: +44 (0) 203 882 9621
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology. Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application, as well as being optimised for clinical efficacy, safety, administration and patient convenience. The products are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk.
MED3000 is Futura's topical gel formulation that is a breakthrough treatment for erectile dysfunction ("ED") through a unique evaporative mode of action. Futura has previously conducted a Phase 3 study using MED3000 in ED, referred to as "FM57". This was a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study delivering highly statistically significant results compared to pre-treatment baseline, using measures IIEF-EF, SEP2 and SEP3 (internationally accepted clinical trial endpoints in ED) with over 60% of patients experiencing a clinically meaningful improvement in their ED.
MED3000 is CE marked in Europe and CA marked in the UK as a clinically proven topical treatment for adult men with erectile dysfunction under the brand Eroxon™ with a key claim of "Helps you get an erection within 10 minutes".
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com