Chiroscience Group - New Data on Anaesthetic
19 Settembre 1997 - 9:31AM
UK Regulatory
RNS No 949c
CHIROSCIENCE GROUP PLC
19th September 1997
LEVOBUPIVACAINE: NEW DATA PRESENTED AT XVIth ANNUAL CONGRESS
OF THE EUROPEAN SOCIETY OF REGIONAL ANAESTHESIA
Chiroscience Group plc last night presented new data on
levobupivacaine, the long acting local anaesthetic, which is
progressing through Phase III trials towards the planned
European regulatory filing in December 1997 and US filing in
April 1998.
Investigators summarised key pre-clinical and clinical
experience to date for levobupivacaine during a satellite
symposium at the XVIth Annual Congress of the European Society
of Regional Anaesthesia (London, 18th September 1997).
Significant new clinical results were presented in the key areas
of major surgery and post-operative pain management.
Clinical investigations using levobupivacaine to provide post-
operative pain control were reported by Dr James C. Crews of the
Bowman Gray School of Medicine, North Carolina. In a trial of
patients undergoing lower limb orthopaedic surgery, a
combination of levobupivacaine and fentanyl was compared to both
drugs used alone. In a second trial involving patients
undergoing major abdominal surgery, the pain control achieved
with a combination of levobupivacaine and morphine was compared
to that of each drug used in isolation.
The results of both trials clearly demonstrated the value of
combining either morphine or fentanyl with levobupivacaine for
post-operative pain control. In addition, the total amounts of
supplementary analgesia required for effective pain control were
reduced. While bupivacaine is not approved in the USA for post-
operative pain management, this data supports such a new claim
for levobupivacaine.
Dr Dan J. Kopacz, of the Virginia Mason Medical Center, Seattle,
reported the results of trials in major surgery comparing
levobupivacaine with bupivacaine using a variety of block
techniques. Levobupivacaine was equivalent in potency to
bupivacaine, with a slightly faster onset and slower offset of
pain relief, but with the same depth of anaesthesia and a
slightly shorter duration of motor block. These results,
combined with the growing evidence of levobupivacaine's lower
cardiovascular and central nervous system side effects, show
that levobupivacaine could be used as a safer, but equally
effective, agent than bupivacaine for regional anaesthesia.
Other presentations at the symposium reviewed the use of
levobupivacaine in obstetric anaesthesia, its neuropharmacology
and its cardiovascular and central nervous system safety
profiles in pre-clinical models. The studies reported are among
the first of a wide range of trials nearing completion, which
will be used to support levobupivacaine's regulatory filings.
Additional new data will be presented at the annual meeting of
the American Association of Anesthesiologists (18-22 October
1997).
For further information contact:
Dr John Padfield, Chief Executive Giles Sanderson
Andrew Burrows, Media Relations Financial Dynamics
Rebecca Iveson, Investor Relations Tel: +44 (0)171 831 3113
Tel: +44 (0)1223 420430
http://www.chiroscience.com
Chiroscience Group plc
Chiroscience is an emerging pharmaceutical company operating in
the UK and USA, which uses its diverse technology platform to
discover and develop novel medicines for improved healthcare.
The Group has two principal activities, operating as Darwin
Discovery and ChiroTech. Chiroscience is listed on the London
Stock Exchange.
Darwin Discovery embraces activities in Cambridge, Seattle and
Stevenage, including gene-based research and molecular biology,
through chiral-based, combinatorial, medicinal and process
chemistries, to clinical development. It is engaged in the
discovery and development of innovative small molecule drugs and
related diagnostics with a therapeutic focus on autoimmune
disease, cancer, inflammation, pain and osteoporosis.
ChiroTech provides chiral technology services to customers
within the pharmaceutical and related industries and in support
of Darwin Discovery's research and development programmes.
END
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