Futura Medical PLC
07 November 2005
For Immediate Release 7 November 2005
Futura Medical plc
Announces preliminary results
from MED2003/4/5 pharmacokinetic study
Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device group
that develops innovative products for the sexual healthcare market, announces
the completion of the first of two clinical trials in healthy male volunteers
(Subjects) to evaluate three novel formulations of its topical gel for the
treatment of erectile dysfunction (ED).
Sixteen Subjects have completed an escalating dose study in which they received
six different gels applied directly to the penis over a three week period
thereby allowing a suitable period of time between each different gel
application. All six gels contained the compound glyceryl trinitrate (GTN)
within three gel formulations, MED2003, MED2004 and MED2005, which have been
developed to deliver GTN into the penile tissues at different rates.
An excellent safety profile was achieved with a dose-related response in terms
of incidence and severity of adverse events based on the strength and rate of
release of GTN from the gels. The adverse events reported were predominantly
mild headaches which were pharmacologically predictable, resolved spontaneously
and did not require treatment. No serious adverse events were recorded and no
falls in blood pressure seen. Levels of GTN within the Subjects' blood plasma
indicate a highly favourable pharmacokinetic profile characterised by rapid
absorption and elimination of the compound. In addition the absorption profile
is consistent with the intended use of the product in the treatment of erectile
dysfunction, suggesting a rapid onset of action, within a few minutes of product
application, and no prolonged side effects.
James Barder, Chief Executive of Futura, said: 'We are greatly encouraged by
these preliminary results of this pharmacokinetic study. We firmly believe we
have identified the correct dose and formulation to deliver a GTN level that is
well tolerated and safe. A second placebo-controlled study investigating the
pharmacodynamic events of these new formulations has recently completed and we
expect to able to release the results of this study towards the end of
November.'
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:
Buchanan Communications
Mark Court / Tim Anderson / Rebecca Dietrich Tel: +44 (0) 20 7466 5000
Notes to Editors:
Futura Medical plc
Futura Medical 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. Exclusive
worldwide distribution agreements have already been signed in respect of
Futura's two condom safety products, CSD500 and FLD500, with SSL International
plc, the makers of DurexTM condoms.
Futura's primary focus is on Over the Counter (OTC) products with particular
appeal to men and women who are reluctant to discuss potentially embarrassing
sexual matters with their doctors.
In March 2005 Futura announced it had entered into exclusive discussions until
31st December 2005 with a major global pharmaceutical group on a proposed
agreement for the worldwide development and marketing of MED2002 (MED2003,
MED2004 & MED2005 are revised formulations of MED2002).
This was to allow time for discussions, joint co-operation and certain
development work on MED2002 to be completed with a view to entering into a
potential global distribution agreement.
Further technical data on the pharmacokinetic study is available upon request.
Phase III trials are scheduled to commence in 2006.
For further information please visit: www.futuramedical.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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