Futura Medical PLC Eroxon(R) Granted Marketing Authorisation in Mexico
25 Oktober 2023 - 8:00AM
RNS Non-Regulatory
TIDMFUM
Futura Medical PLC
25 October 2023
25 October 2023
Futura Medical plc
("Futura" or the "Company")
Eroxon (R) Granted Marketing Authorisation in Mexico
Futura Medical plc (AIM: FUM), the pharmaceutical company
developing innovative sexual health products, today announces that
the Mexican Secretariat of Health has granted over the counter sale
("OTC") Marketing Authorisation for Eroxon (R) , the Company's
breakthrough, topical gel formulation for the treatment of erectile
dysfunction ("ED").
Eroxon(R) can now be marketed in Mexico as a topical treatment
for ED available OTC without the need for a prescription. Eroxon(R)
is approved as an effective, clinically proven treatment for ED
with a 10-minute onset of action.
The prevalence of ED disrupts the lives of at least 1 in 5 men
globally(1) . Mexico currently has a population of 129 million (2)
.
MED3000 has already been approved as the first pan-European
clinically proven topical treatment for ED available OTC and is now
available in a growing number of EU and Middle East markets. I
nitial launches commenced under the brand name Eroxon(R) in March
2023, w ith commercial agreements in key markets including the
European Economic Area, UK, Switzerland, South Korea, Latin America
and the Middle East.
James Barder, Chief Executive Officer of Futura said :
"Following the approval by the US FDA earlier this year, Mexican
marketing authorisation opens up another very large and exciting
market for Eroxon(R) . Mexico is a vibrant and dynamic market, and
we look forward to bringing the benefits of Eroxon(R) to ED
sufferers in Mexico with our commercial partner M8."
EMA, Withdrawal assessment report for Viagra, 2008
1. EMA, Withdrawal assessment report for Viagra, 2008
2. https://www.unfpa.org/data/world-population/MX
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
For media enquiries please contact:
Optimum Strategic Communications
Nick Bastin / Jonathan Edwards / Zoe Bolt / Elena Bates
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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