Futura Medical PLC MED3000 Granted US FDA Approval for OTC Sale (3215C)
12 June 2023 - 4:00PM
UK Regulatory
TIDMFUM
RNS Number : 3215C
Futura Medical PLC
12 June 2023
12 June 2023
Futura Medical plc
("Futura" or the "Company")
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(R) 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
globally(1) 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. I nitial launches commenced under
the brand name Eroxon(R) in March 2023 with further launches
planned through 2023 and beyond w ith 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.
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
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
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(R) technology. Each DermaSys(R)
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. 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 novel
treatment for erectile dysfunction (ED) through a unique
evaporative mode of action. Futura has conducted two Phase 3
studies using MED3000 in ED; FM57 study which enabled Futura to be
granted a CE Mark in 2021 and FM71 which enabled Futura to be
granted US marketing authorisation. Both studies demonstrated 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 an 'Over the Counter'
classification.
Eroxon(R) is FDA approved in the US, CE marked in Europe and
UKCA marked in the UK as a clinically proven topical treatment for
adult men with erectile dysfunction under the brand Eroxon(R) with
a key claim of "Helps you get an erection within 10 minutes".
Eroxon(R) is the agreed brand name in certain regions such as the
EU whereas MED3000 continues to be the internal code name used by
the Company and also in reference to countries where regulatory
approval or commercial distribution agreements have not yet been
achieved. www.eroxon.com
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange.
www.futuramedical.com
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