REG - Futura Medical PLC - Update on MED3000 regulatory approval in the US

Futura MedicalAnnouncement

29/03/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230329:nRSc5422Ua&default-theme=true

RNS Number : 5422U  Futura Medical PLC  29 March 2023

 

 

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
(mailto:Investor.relations@futuramedical.com)

Tel: +44 (0) 1483 685 670

www.futuramedical.com (http://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/
(http://www.futuramedical.com/)

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDBVLLLXXLXBBD