Last checked at 29 Mar 2023 07:00
29 March 2023
Futura Medical plc
("Futura" or the "Company")
Update on progress towards regulatory approval in the US
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 provides an update on US regulatory activities for MED3000, Futura's novel, topical gel formulation for the treatment of erectile dysfunction ("ED").
Following the FDA update provided by the Company on 14 March 2023, Futura can confirm that a full response to the FDA's questions, as well as the requested confirmatory data, has been resubmitted to enable the FDA to continue its review.
Based on the FDA's published target review period guidelines which includes time to review the newly provided information, the Board continue to anticipate grant of the De Novo request in Q2 2023.
-ENDS-
For further information, please contact:
Futura Medical plc
James Barder, Chief Executive Officer
Angela Hildreth, Finance Director and COO
Email: investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
www.futuramedical.com
Nominated Adviser and Sole Broker:
Liberum
Phil Walker/ Richard Lindley/ Ben Cryer/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Hollie Vile/ Jonathan Edwards/ Zoe Bolt
Email: futuramedical@optimumcomms.com
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. A second confirmatory Phase 3 clinical study, "FM71" was also conducted to support Futura's regulatory submission to the FDA with 96 ED patients and endpoints at 24 weeks, demonstrating 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.
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/