Reformulation of treatment
Futura Medical PLC
12 July 2004
Press Release 12 July 2004
Futura Medical announces completion of
reformulation work on Erectile Dysfunction treatment
Futura Medical plc ('Futura'), the AIM-quoted pharmaceutical drug and medical
device group that develops innovative products for the sexual healthcare market,
has completed the reformulation of its topically applied treatment for Erectile
Dysfunction ('ED').
Initial testing of the revised formulation has demonstrated dramatic
improvements in dermal absorption rates, compared with the previous formulation.
It maximises local effects in the penis whilst minimising systemic uptake
throughout the body. This will reduce the risk of harmful interaction with
other centrally acting drugs that may also be taken by the patient, especially
PDE5 inhibitors such as ViagraTM, CialisTM or LevitraTM, and improve the chances
of an Over The Counter ('OTC') status being granted for MED2002. Greater dermal
absorption rates will also deliver the active ingredient more rapidly to the
penis, which should further improve the time to onset of an erection.
Clinical studies, to be completed later this year, will establish the optimum
dose for the new formulation prior to the start of the pivotal Phase III study
for MED2002.
The reformulation, along with the recently completed angina study and the design
and completion of a novel applicator system, represent significant progress for
the product. James Barder, Chief Executive of Futura, said: 'Both Futura and
our potential distribution partners are delighted by the progress being made on
this project and the major value-added benefits of these recent developments.'
For further information:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 845 670
mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk
Media enquiries:
Bankside
Peter Curtain / Alex Tweed Tel: +44 (0) 20 7444 4140
mailto:alexandra.tweed@bankside.com www.bankside.com
Notes to Editors:
Futura Medical plc
Futura Medical ('Futura' or 'the Company') is an AIM-listed pharmaceutical drug
and medical device group developing innovative products for sexual health. The
Company is developing a portfolio of products with the intention of licensing
their manufacture and distribution to major pharmaceutical and healthcare
groups. Several distribution agreements have been signed.
Futura's primary focus is on novel Over the Counter ('OTC') products, which
provide more available treatments for men and women compared with prescription
medicines. These products have particular appeal to men and women who are
reluctant to discuss potentially embarrassing sexual matters with their doctors.
In June 2003 the Company's first product, MED2001 (now reformulated as MED2002),
a rub-on cream for erectile dysfunction (ED), completed a Phase II study, which
demonstrated a good safety profile and efficacy trends. The new formulation,
MED2002, is likely to enter Phase III trials by early 2005.
A trial to assess the safety of the ED treatment in angina patients has been
completed. Normal medications taken by angina patients prevent the use of
available ED treatments such as ViagraTM, CialisTM and LevitraTM.
The Company's second product is CSD500, a latex condom incorporating a gel
within the teat which will help healthy men maintain an erection throughout
intercourse, so reducing the likelihood of condom slippage.
FLD500, which is aimed primarily at female partners of male condom users and
will help women maintain lubrication during intercourse, thereby reducing the
risk of condom failure, is currently undergoing clinical trials at the
Porterbrook Clinic in Sheffield.
www.futuramedical.co.uk
This information is provided by RNS
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