Goldshield Grp PLC - Re Marketing Authorisation
February 09 1999 - 3:00AM
UK Regulatory
RNS No 3449h
GOLDSHIELD GROUP PLC
9th February 1999
GOLDSHIELD GROUP
DICLOFENAC 2% SPRAY
Application for marketing authorisation
A Product Licence Application has been submitted for
Goldshield Diclofenac 2% Spray under the Mutual
Recognition Procedure in the UK. The directors of
Goldshield expect that, subject to regulatory approval,
the product will go on sale in the last quarter of 1999.
This product uses Goldshields patented technology for
the rapid and effective delivery of drugs through the
skin after topical application by spray. The spray
contains the anti-inflammatory drug Diclofenac for the
treatment of acute and chronic joint pain.
Clinical studies examining pain response were conducted
on 40 patients with chronic osteoarthritis of the knee.
The Goldshield product resulted in clinical benefits
giving pain relief at least equivalent to other available
remedies over the first few days but gave significantly
more rapid onset in pain relief.
In contrast to currently available topical gel
formulations the metered delivery of Goldshield
Diclofenac Spray gives a precise dose for each actuation
of the spray, allowing the patient to control exactly the
administered dose. This is particularly useful for
patients with chronic arthritic conditions who need to
establish an effective dose and regulate the total dose
of medicine that they receive.
Blood levels of Diclofenac were also measured in patients
since a major advantage of topically administered
products is that the harmful effects on other parts of
the body are reduced due to much lower levels of the drug
being absorbed into the bloodstream. Blood levels of
Diclofenac with the Goldshield product were confirmed as
being very low.
With the in-vitro skin and patient studies suggesting a
more rapid absorption of Diclofenac from the Goldshield
product it confirms the superior performance of its
transphase system for enhanced drug delivery. This result
is encouraging both for the Diclofenac spray and for
other products under development.
The Non-Steroidal Anti-inflammatory Drug Market in the UK
is currently worth #241 million, of which 15% is topical
gels and 85% is oral therapy. Diclofenac Tablets equate
to 25% of the oral therapy market and Diclofenac Gels
equate to 16% of the topical gel market. Several of the
Non-Steroidal Anti-inflammatory drugs, including
Diclofenac products, are marketed throughout Europe.
Ajit Patel, Chairman and Chief Executive of Goldshield
said today:
"We are delighted that this exciting product has now
passed its clinical trial and we look forward to being
able to market this product in the UK and licence the
product to interested parties in Europe."
Contact:
Goldshield Group plc 0181 649 8500
Ajit Patel, Chairman & Chief Executive
Buchanan Communications 0171 466 5000
Andy Yeo/Tom Gadsby
END
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