Futura Medical PLC FDA regulatory and commercial update for MED3000 (5836F)
19 Julio 2021 - 1:00AM
UK Regulatory
TIDMFUM
RNS Number : 5836F
Futura Medical PLC
19 July 2021
19 July 2021
Futura Medical plc
Futura provides FDA regulatory and commercial update for
MED3000
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 and currently focused on sexual health and
pain, is pleased to provide an update on FDA regulatory processes
and commercial activities for MED3000.
US regulatory progress
Last week Futura met with the FDA for a pre-submission meeting
to define and confirm the detail of the work required for OTC
classification in the USA for MED3000, the Company's breakthrough
fast acting clinically proven treatment for erectile dysfunction
("ED").
The Company is pleased to confirm that the FDA has agreed to the
design of the non-clinical, Human Factors Study, subject to the
issue of the final meeting minutes. The study will test the ability
of subjects to self-diagnose their ED, correctly select the product
based on label information and test their ability to correctly use
the product without supervision of a doctor. The FDA has asked for
a minimum of 15 subjects to complete the study.
As previously communicated, comprehensive planning and
preparation activities including active site selection are well
underway for the commencement of FM71, the required confirmatory
clinical study, with the first patient dosing expected during Q3
2021 targeting completion of the FM71 study and Human Factors study
for Q2 2022. US OTC marketing authorisation remains on track for
approval for MED3000 in Q1 2023.
Commercial progress
Manufacturing scale up and capacity to meet projected demand is
progressing well in conjunction with commercial out-licensing
agreements covering the remaining major regions and countries of
the world with a number of interested parties. As previously
outlined, Futura expects to be able to update shareholders further
during the remainder of 2021 as it looks to target the launch of
MED3000 during 2022.
MED3000, is a topical gel which utilises our proprietary
technology DermaSys(R), developed specifically for the treatment of
erectile dysfunction ("ED"). It is a fast-acting topical treatment
which has the potential to be a highly differentiated product by
addressing significant unmet needs in the ED market.
James Barder, Chief Executive of Futura Medical commented:
"Subject to receipt of the final meeting minutes we are pleased
that the requirements to enable an OTC application for MED3000 have
been clarified with the FDA. In addition, we remain focused on
preparation and execution of the FM71 study with the first patient
dosing expected later this year . The USA remains the largest
market opportunity globally for ED treatments and we are making
steady progress on attaining approval for MED3000 in the
region."
-ENDS-
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
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
Richard Lindley/ Euan Brown/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 20 3922 0900
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. 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 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, consistently meeting all co-primary endpoints of IIEF,
SEP2 and SEP3 (internationally accepted clinical trial endpoints in
ED) with over 60% of patients experiencing a clinically meaningful
improvement in their ED. MED3000 also begins to work immediately in
some patients, with 60% of patients seeing onset of their erection
within 10 minutes of application. MED3000 is CE marked in Europe
and the UK as a clinically proven topical treatment for adult men
with erectile dysfunction.
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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END
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