Sativex phase IIb pain trial results publication (8158B)
April 23 2012 - 2:00AM
UK Regulatory
TIDMGWP
RNS Number : 8158B
GW Pharmaceuticals PLC
23 April 2012
Publication of full Sativex(R) phase IIb pain trial results
in official journal of the American Pain Society
London, UK; Tokyo, Japan; April 23 2012: GW Pharmaceuticals plc
(AIM: GWP) and Otsuka Pharmaceutical Co., Ltd. today announce the
publication in the Journal of Pain(1), the official journal of the
American Pain Society, of the full results from a Phase IIb
dose-ranging trial evaluating the efficacy and safety of Sativex(R)
(USAN: Nabiximols) in the treatment of pain in patients with
advanced cancer, who experience inadequate analgesia during
optimized chronic opioid therapy.
This Phase IIb study was the first major trial carried out by GW
and Otsuka Pharmaceutical as part of the development program aimed
at securing regulatory approval for Sativex(R) from the Food &
Drug Administration (FDA) in the United States. Top line results
from this study were originally reported in March 2010 and a Phase
III trials program has since commenced.
According to the publication's lead author, Dr. Russell K.
Portenoy, Chairman of the Department of Pain Medicine and
Palliative Care at Beth Israel Medical Center in New York City.
"Many patients with advanced cancer do not attain adequate pain
relief from an opioid regimen, or experience opioid side effects
that limit the doses of opioids the patients can receive. The
finding in this dose ranging study that Sativex(R) has potential
analgesic efficacy as add-on therapy for pain due to advanced
cancer that is poorly responsive to opioid therapy has great
potential clinical relevance. Phase III confirmatory studies are
strongly warranted and, if positive, may provide an opportunity to
address a significant clinical challenge."
Two placebo-controlled multi-centre multinational Phase III
cancer pain studies are now underway. Each Phase III trial is
intended to recruit 380 patients. A third Phase III study is due to
commence this year. The primary efficacy endpoint in the Phase III
trials program is the continuous responder analysis (an analysis of
all response levels characterized by percent improvement) of
average daily pain from baseline to end of study as measured using
a 0-10 Numeric Rating Scale (NRS). This Phase III trials program is
funded by Otsuka.
(1)
http://www.jpain.org/article/S1526-5900(12)00019-3/abstract
Enquiries:
GW Pharmaceuticals plc (Today) + 44 20 7831 3113
Dr Geoffrey Guy, Chairman (Thereafter) + 44 1980
557000
Justin Gover, Managing Director
FTI Consulting + 44 20 7831 3113
Ben Atwell / John Dineen
Peel Hunt LLP +44 207 418 8900
James Steel / Vijay Barathan
Notes to Editors:
Sativex(R) in Cancer Pain
Treatment of pain in patients with advanced cancer, who
experience inadequate analgesia during optimized chronic opioid
therapy represents the initial target indication for Sativex(R) in
the United States. All trials in this indication are being
performed by GW and Otsuka under the terms of an exclusive license
and development agreement to develop and market Sativex(R) in the
US. Data generated from this trials program is also intended to be
used by GW for regulatory submissions in the rest of the world.
In addition to the Phase IIb trial, a previous Phase IIa study
has also been published in the Journal of Pain and Symptom
Management, the Official Journal of the American Academy of Hospice
and Palliative Medicine, the National Hospice and Palliative Care
Organization, and the U.S. Cancer Pain Relief Committee (J Pain
Symptom Manage.2010 Feb;39(2):167-79). In total, the Phase II
program comprises over 500 patients.
Sativex(R) in Multiple Sclerosis
Sativex(R) is currently available as a prescription medicine for
the treatment of spasticity associated with multiple sclerosis in
the UK, Spain, Germany, Denmark, Canada and New Zealand.
Sativex(R) is indicated as treatment for symptom improvement in
patients with moderate to severe spasticity due to multiple
sclerosis (MS) who have not responded adequately to other
anti-spasticity medication (i) and who demonstrate clinically
significant improvement in spasticity related symptoms during an
initial trial of therapy.(1)
About Otsuka Pharmaceutical Co., Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global
healthcare company with the corporate philosophy: 'Otsuka-people
creating new products for better health worldwide.' Otsuka
researches, develops, manufactures and markets innovative and
original products, with a focus on pharmaceutical products for the
treatment of diseases and consumer products for the maintenance of
everyday health. Otsuka is committed to being a corporation that
creates global value, adhering to the high ethical standards
required of a company involved in human health and life,
maintaining a dynamic corporate culture, and working in harmony
with local communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of
Otsuka Holdings Co., Ltd., the holding company for the Otsuka
Group. The Otsuka Group has business operations in 23 countries and
regions around the world, with consolidated sales of Yen1,090.2
billion for fiscal year 2010.
For more information, please visit www.otsuka.co.jp/en.
About GW
GW was founded in 1998 and listed on the AIM, a market of the
London Stock Exchange, in June 2001. Operating under license from
the UK Home Office, the company researches and develops cannabinoid
pharmaceutical products for patients who suffer from a range of
serious ailments, in particular multiple sclerosis and cancer pain.
GW has assembled a large in-house scientific team with expertise in
cannabinoid science as well as experience in the development of
both plant-based prescription pharmaceutical products and medicines
containing controlled substances. GW occupies a world leading
position in cannabinoids and has developed an extensive
international network of the most prominent scientists in the
field. For further information, please visit www.gwpharm.com
This news release may contain forward-looking statements that
reflect GWs current expectations regarding future events, including
development and regulatory clearance of the GW's products.
Forward-looking statements involve risks and uncertainties. Actual
events could differ materially from those projected herein and
depend on a number of factors, including (inter alia), the success
of the GW's research strategies, the applicability of the
discoveries made therein, the successful and timely completion of
uncertainties related to the regulatory process, and the acceptance
of Sativex(R) and other products by consumer and medical
professionals.
(i) Sativex(R) Summary of Product Characteristics, 2011.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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