Futura Medical PLC Futura files for Further Pre-Submission meeting (1063K)
20 Abril 2020 - 1:00AM
UK Regulatory
TIDMFUM
RNS Number : 1063K
Futura Medical PLC
20 April 2020
20 April 2020
Futura files for Further Pre-Submission meeting with the FDA
following receipt of its Phase 3 clinical study report
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)
technology and currently focused on sexual health and pain, is
pleased to announce that it has now filed for a further
pre-submission meeting with the US FDA following receipt of the
complete and signed clinical study report (CSR) for its Phase 3
Study (FM57). This follows initial presentation of existing
clinical evidence from the FM57 study at an FDA pre-submission
meeting on 24(th) February 2020.
FM57 reported top line results in December 2019. It was a 1,000
patient, dose-ranging, multi-centre, randomised, double blind,
placebo-controlled, home use, parallel group study for the
Company's lead product, MED3000, a topical treatment for Erectile
Dysfunction (ED). It demonstrated that MED3000 has the potential to
be a highly effective, clinically proven, topical treatment for ED,
with a fast onset of action and excellent safety profile.
As disclosed on 6 April 2020, the US FDA has agreed to a De Novo
medical device application for MED3000 subject to Futura pursuing
another pre-submission meeting to further discuss clinical
sufficiency and/or post-marketing requirements, with reference to
the full FM57 CSR and other supporting information. Futura has now
filed for the pre-submission meeting and expects this second
meeting to take place in the coming months. If the outcome of the
meeting is positive, this could lead to a US submission filing in
Q3 2020 for FDA review for pre-marketing clearance.
James Barder, Chief Executive of Futura Medical, commented:
"Following extensive review of the clinical data, we are pleased to
have received the completed and signed CSR for FM57, and have filed
the necessary data in order for the company to have the next
pre-submission meeting to further discuss clinical sufficiency
and/or post-marketing requirements for MED3000. As a breakthrough
treatment for erectile dysfunction (ED), we are confident that we
will receive MED3000 approval as a medical device, and we continue
to target the next six months for regulatory submissions in both
Europe and USA."
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
Bidhi Bhoma/ 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) 203 950 9144
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.
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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