TIDMGWP
RNS Number : 1453C
GW Pharmaceuticals PLC
02 March 2011
Positive Sativex(R) Phase III Study in MS Spasticity Published
in European Journal of Neurology
Porton Down, UK, 2 March 2011: GW Pharmaceuticals (AIM: GWP)
announces that positive results from a Phase III clinical study of
Sativex(R) Oromucosal Spray (delta-9-tetrahydrocannabinol (THC) and
cannabidiol (CBD)) in multiple sclerosis (MS) spasticity have been
published in the European Journal of Neurology Early View
[http://onlinelibrary.wiley.com/doi/10.1111/j.1468-1331.2010.03328.x/abs
tract]. The paper is published online and will appear in the print
copy of the Journal in the coming months. Preliminary headline
results of this study have been previously announced by GW.
The full text of the release issued for the medical press by
Bayer Schering Pharma, GW's UK marketing partner for Sativex(R) ,
follows below.
Sativex(R) improves symptoms of spasticity due to MS, study
shows
Newbury, Berkshire, 2 March 2011 - Results from a phase III
clinical study published online yesterday in the European Journal
of Neurology Early View
[http://onlinelibrary.wiley.com/doi/10.1111/j.1468-1331.2010.03328.x/abs
tract] showed that about half of all people with moderate to severe
spasticity due to multiple sclerosis (MS) who have not responded
adequately to standard anti-spasticity therapy, find that adding
Sativex(R) Oromucosal Spray (delta-9-tetrahydrocannabinol (THC) and
cannabidiol (CBD)), to their existing medication can improve the
debilitating symptoms of spasticity associated with MS.(1)
The primary efficacy endpoint was the change in a validated, 10
point (0-10) self-reported spasticity numerical rating scale (NRS)
from the point of randomisation to the end of the treatment.(1)
Sativex(R) was shown to provide significant improvement, compared
to placebo, in the NRS spasticity score, spasm frequency and sleep
disturbance related to spasticity.(1)
After a four-week, single-blind therapeutic trial period in 572
patients, Sativex(R) reduced the mean NRS score for spasticity by
3.01 points, from a baseline of 6.91 points.(1) 48% of patients
achieved a clinically meaningful improvement of >=20% in
spasticity severity during this initial period.(1) Of these
responders, 241 proceeded into a 12-week, randomised,
placebo-controlled trial phase.(1) At the end of the trial,
Sativex(R) had reduced the mean spasticity 0-10 NRS score in
responders by significantly more than placebo (estimated treatment
difference 0.84 points; p=0.0002).(1) The number of patients
achieving an improvement in spasticity NRS of >=30% by the end
of the trial was significantly greater in the Sativex(R) group than
the placebo group (74% vs. 51%; p=0.0003).(1)
Professor John Zajicek, Honorary Consultant in Neurology,
Derriford Hospital and Chair of Clinical Neurosciences at PCMD,
University of Plymouth said, 'We have been aware for a long time
that cannabinoid medicines can significantly improve spasticity,
which is a common, complex symptom of MS, and now the results from
this study prove the positive impact they can have on patients'
symptoms, and ultimately their lives.'
- ends -
For further information, please contact:
Medical press enquiries.
Kim Lemon / Danielle Smith
Liberation Communications
Mob: + 44 (0) 7771 561079 / +44 (0) 7595 412222
E-mail: kim@liberationcomms.com /
danielle@liberationcomms.com
Other enquiries:
GW Pharmaceuticals plc
Dr Geoffrey Guy, Chairman Today: +44 (0) 20 7831 3113
Justin Gover, Managing Director Thereafter: + 44 (0) 1980 557000
Peel Hunt LLP (Nominated Adviser)
James Steel
Vijay Barathan +44 (0) 20 7418 8900
Financial Dynamics
Ben Atwell / John Dineen + 44 (0) 20 7831 3113
Note to Editors
About MS
Multiple sclerosis (MS) is a condition that affects
approximately 100,000 people in the UK in which damage occurs
within the central nervous system (CNS - brain and spinal cord).(2)
As the nerves of the CNS control the functions of the whole body,
symptoms can affect many different areas.(3) MS is the most common
disabling disease of the CNS affecting young adults and is usually
diagnosed between the ages of 20 and 40 years.(3,4) MS is twice as
common in women than in men. (3,4)
More information can be found on the following websites:
-- MS Society http://www.mssociety.org.uk/
-- MS Trust http://www.mstrust.org.uk/
About spasticity
Spasticity is a common symptom associated with MS(5) and is a
major contributor to disability.(6) It is caused by damage to the
nerves in the central nervous system which carry messages
instructing muscles how to move resulting in an involuntary muscle
over activity.(7)
In a survey, 84% of people with MS reported symptoms of
spasticity.(8) Moderate, severe or total spasticity is reported in
34% of individuals.(8) Symptoms include loss of coordination and
mobility, painful spasms, stiffness and/or weakness of muscles.(7)
As a consequence an individual may have difficulty in walking,
picking up objects, washing, dressing and other everyday activities
involving movement.(5) In addition to causing a great deal of
distress to the person with MS, mood, self-image and motivation can
also be affected.(9)
About the study(1)
A 19-week follow-up, multicentre, double-blind, randomised,
placebo-controlled, parallel-group study in subjects with MS
spasticity not fully relieved with current anti-spasticity therapy.
Subjects were treated with Sativex(R) , as add-on therapy, in a
single-blind manner for 4 weeks, after which those achieving an
improvement in spasticity of >=20% progressed to a 12 week
randomised, placebo-controlled phase.
About Sativex(R)
Sativex(R) was developed by UK-based GW Pharmaceuticals plc in
specific response to the MS population's unmet need for a
prescription cannabis based medicine. Manufactured under Home
Office licence at an undisclosed location in the UK, Sativex(R) is
marketed in the UK by Bayer Healthcare.
Sativex(R) is indicated as add-on treatment for symptom
improvement in patients with moderate to severe spasticity due to
MS who have not responded adequately to other anti-spasticity
medication and who demonstrate clinically significant improvement
in spasticity related symptoms during an initial trial of
therapy.(10) There are around 100,000 people with MS in the UK(2) ,
with 84% reporting symptoms of spasticity.(8) Of these,
approximately 11,500 do not respond adequately to standard therapy
and would therefore be eligible for treatment with Sativex(R) .(8)
About 50% of this treatment-resistant group will have a good
response to Sativex(R) in an initial trial of therapy and will
continue to do so when taking Sativex(R) for an extended period of
time.(11)
Sativex(R) contains active ingredients called 'cannabinoids'
which are extracted from cannabis plants grown and processed under
strictly controlled conditions. Cannabinoids bind to cannabinoid
receptors that occur naturally throughout the body, particularly in
the central nervous system, and can result in the inhibition of
nerve impulses.(12) The detailed mode of action of cannabinoids is
the subject of continuing research, but in simple terms Sativex(R)
can reduce the overactivity of MS-damaged nerves that can result in
spasticity. In responding patients, Sativex(R) added to existing
anti-spasticity medication will therefore improve spasticity
symptoms, reducing painful spasms and facilitating an improvement
in the activities of daily living.
Sativex(R) is primarily made up of a 1:1 ratio of two particular
cannabinoids - cannabidiol (CBD) and delta-9-tetrahydrocannabinol
(THC).(13) The CBD:THC formulation is believed to provide maximum
clinical efficacy - a significant decrease in MS spasticity - with
the minimum of unwanted THC-related side effects.(13)
Main effects of CBD and THC: (14)
CBD THC
-------------------------------------- --------------------------------------
Anti-inflammatory, anticonvulsant, Analgesic, anti-spasmodic,
antipsycotic, anti-oxidant, anti-tremor, anti-inflammatory,
neuroprotective, immunomodulatory appetite stimulant, anti-emetic
-------------------------------------- --------------------------------------
The most common side effects of Sativex(R) are dizziness, which
occurs mainly in the first few weeks of treatment, and fatigue.
These reactions are usually mild to moderate and improve within a
few days even if treatment is continued.(10)
Sativex(R) is only available on prescription from a physician
with experience in treating MS spasticity.(10) It is sprayed into
the mouth either onto the inside of the cheek or under the tongue.
The MS patient decides how many sprays they need in any one day,
with the typical dose of 8 sprays a day seen in clinical trials
(maximum recommended dose of 12 sprays).(10) The NHS price of
Sativex(R) is GBP125 per 10ml vial which for a typical patient is
approximately GBP11 per day.(15)
( )
Sativex(R) is a registered trade mark of GW Pharmaceuticals and
they are the Marketing Authorisation holder for Sativex(R) .
More information for the press can be found at
www.sativex.co.uk
About Bayer
Bayer is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following
areas: Diagnostic Imaging, General Medicine, Haematology &
Neurology, Oncology and Women's Healthcare. With innovative
products, Bayer aims for leading positions in specialised markets
worldwide. Using new ideas, Bayer aims to make a contribution to
medical progress and strives to improve the quality of patients'
lives.
Further information can be found at www.bayer.co.uk
About GW Pharmaceuticals plc
GW Pharmaceuticals plc (AIM: GWP) was founded in 1998 and is
listed on the AiM, a market of the London Stock Exchange. Operating
under licence 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 MS 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
Forward-Looking Statements
This release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer Group or subgroup
management. Various known and unknown risks, uncertainties and
other factors could lead to material differences between the actual
future results, financial situation, development or performance of
the company and the estimates given here. These factors include
those discussed in Bayer's public reports which are available on
the Bayer website at www.bayer.com. The company assumes no
liability whatsoever to update these forward-looking statements or
to conform them to future events or developments.
References
1. Novonta A, et al. A randomised, double-blind,
placebo-controlled, parallel-group, enriched-design study of
nabiximols (Sativex(R) ), as add-on therapy, in subjects with
refractory spasticity due to multiple sclerosis. European Journal
of Neurology Early View.
http://onlinelibrary.wiley.com/doi/10.1111/j.1468-1331.2010.03328.x/abst
ract (Last accessed: 01/03/2011)
2. Multiple Sclerosis Society. About MS. Available at
http://www.mssociety.org.uk/about_ms/index.html (Last accessed:
14/04/2010)
3. Multiple Sclerosis Trust. MS Explained. 2008. Available at
http://www.mstrust.org.uk/information/publications/msexplained/
(Last accessed: 14/04/2010)
4. NHS Choices. Multiple Sclerosis Introduction. Available at
http://www.nhs.uk/conditions/multiple-sclerosis/pages/introduction.aspx
(Last accessed: 22/04/2010)
5. Multiple Sclerosis Trust. Multiple Sclerosis Information for
Health and Social Care Professionals. 2007. Available at
http://www.mstrust.org.uk/downloads/ms_information_for_hps.pdf
(Last accessed: 14/04/2010).
6. Beard S, et al. Treatments for spasticity and pain in
multiple sclerosis: a systematic review. Health Technol Assess
2003;7(40)
7. Multiple Sclerosis Trust. Spasticity and Spasms factsheet.
November 2009
8. Rizzo MA, et al. Prevalence and treatment of spasticity
reported by multiple sclerosispatients. Multiple Sclerosis
2004;10:589/595
9. Multiple Sclerosis International Federation. Spasticity in
MS. MS in focus. Issue 12. 2008. Available at
http://www.msif.org/docs/MSinFocusIssue12EN.pdf (Last accessed:
14/04/2010).
10. Sativex(R) Summary of Product Characteristics, 2010
11. Wade DT, et al. Long-term use of a cannabis-based medicine
in the treatment of spasticity and other symptoms in multiple
sclerosis. Multiple Sclerosis 2006; 12: 639-645.
12. GW Pharmaceuticals. Cannabinoid Science: Mechanism of
action. Available at
http://www.gwpharm.com/mechanism-of-action.aspx (Last accessed:
01/02/11)
13. GW Pharmaceuticals. Sativex Frequently Asked Questions. What
is Sativex? Available at http://www.gwpharm.com/sativex-faqs.aspx
(Last accessed: 01/02/11)
14. GW Pharmaceuticals. Cannabinoid Science: Cannabinoid
Compounds. Available at http://www.gwpharm.com/types-compounds.aspx
(Last accessed: 01/02/11)
15. Sativex(R) Prescribing Information, 2010
This information is provided by RNS
The company news service from the London Stock Exchange
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