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Sativex® Phase III Neuropathic Pain Trials Demonstrate
Benefits for High Need Treatment-Resistant Patients
GW Pharmaceuticals plc ("GW") today announces preliminary
results of two Phase III studies of Sativex®, its cannabinoid spray
medicine, in peripheral neuropathic pain. These studies are part
of a program to generate data for the future expansion of the use
of Sativex in Europe beyond Multiple Sclerosis (MS) into other pain
conditions.
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Back To Main Medical Reports Page
15 January 2007
The results of the study in patients with neuropathic pain characterised by
allodynia show that patients taking Sativex obtain clinically important
improvements in their management of pain and quality of sleep. In comparison
with placebo, statistically significant improvements were seen for key
outcome measures, including a positive result in the primary analysis of
patient response, the outcome measure recommended by regulatory authorities.
The results of the study in patients with painful diabetic neuropathy show
that patients taking Sativex obtained substantial improvements in their
pain, indeed among the highest level of response seen in the published
literature. There was an abnormally large placebo response in this study,
which means that the data are more difficult to interpret categorically.
Dr Stephen Wright, GW's R&D Director, said, "Neuropathic pain is one of
the
most difficult types of chronic pain to treat. These studies focused on
particularly high need patients, who were already taking the best available
pain treatments, and yet still suffered severe pain. Even in this most
difficult to treat population, Sativex has produced improvements over and
above current treatments that are highly meaningful to the everyday lives of
patients."
These two studies form part of a programme of neuropathic pain trials
conducted to date by GW and reinforce the large body of positive data
already generated. These data contribute significantly to a future
regulatory filing in the use of Sativex as a treatment for neuropathic pain.
GW intends to continue to add to this evidence base.
Allodynia Study
This multi-centre double-blind, randomised, placebo-controlled parallel
group study in 246 patients examined the effect of Sativex in patients with
neuropathic pain characterised by allodynia. Allodynia is the occurrence of
pain in response to a normally non-painful stimulus (e.g. clothes touching
against the skin). It is often intense and can occur in patients suffering
from a range of conditions that damage the peripheral nerves (e.g. nerve
lesions, post-herpetic neuralgia). Patients in this study were being treated
with a range of currently available analgesics, which were maintained during
the course of the study.
The results of this study confirm the efficacy of Sativex. The responder
analysis of the primary endpoint (the proportion of patients obtaining a
clinically meaningful improvement in pain relief), was statistically
significantly in favour of Sativex (p=0.03) for the full Intention to Treat
(ITT) population. In addition, two of the key pain-related secondary
efficacy endpoints, the Patient's Global Impression of Change (p<0.03) and
the assessment of sleep quality (p<0.01), were also statistically
significantly in favour of Sativex. All the other secondary efficacy
endpoints were in favour of Sativex.
European and US regulators recommend a responder analysis of the primary
endpoint in pain studies as the key assessment of outcome. This analysis was
positive and confirms that Sativex produces a clinically important benefit
over and above currently available treatments in a meaningful proportion of
otherwise treatment-resistant patients. An additional analysis of the mean
endpoint data was strongly in favour of Sativex and approached statistical
significance.
Diabetic Neuropathy Study
This multi-centre double-blind, randomised, placebo-controlled parallel
group study in 297 patients examined the effect of Sativex in patients with
painful diabetic neuropathy. Patients in this study were being treated with
a range of currently available analgesics, which were maintained during the
course of the study.
In this study, patients taking Sativex showed a 30% mean improvement in pain
scores, among the highest level of response seen in the published
literature. One third of Sativex patients achieved over a 50% improvement in
pain. However, the study results are difficult to interpret due to an
abnormally large response in the placebo group. As such, although all
outcome measures compared to placebo are in favour of Sativex, they do not
reach statistical significance.
With regard to safety, the pattern of adverse events in both studies was
similar to that seen in other Sativex studies.
Peripheral neuropathic pain forms part of a regulatory strategy to obtain
approvals for Sativex across major markets in a range of indications,
including MS symptoms, central neuropathic pain and cancer pain. Sativex is
the subject of an ongoing regulatory application in four selected European
countries for the symptomatic relief of spasticity in MS. Upon initial
approval, it is intended to extend the MS spasticity indication into other
European countries through the mutual recognition procedure. Since the rules
do not permit a parallel regulatory application in neuropathic pain, GW's
regulatory strategy for this indication is to continue to build the clinical
evidence base whilst the MS spasticity regulatory process is ongoing. Hence,
additional confirmatory trials have been under preparation for some months
and ethics committee approvals obtained. With the benefit of today's
results, the designs of the additional studies can be finalised prior to
their commencement. These studies will further contribute to a future
regulatory submission in neuropathic pain.
Sativex is approved and marketed in Canada for the symptomatic relief of
central neuropathic pain in MS, and is the subject of an ongoing regulatory
submission in Canada for the relief of cancer pain.
------------------------------------------------------------------------------------------------------------
These results are significant because neuropathic pain affects an estimated one
percent
of the world's population and is typically unresponsive to both opioids
and non-steroidal
anti-inflammatory drugs. Previous
trials on Sativex as well as inhaled cannabis have shown
similar results for HIV-related neuropathy and cancer pain.
Sativex is legal in Canada by
Prescription for the treatment of MS-associated neuropathy.
Results of a major US trial assessing the use of smoked cannabis to treat
neuropathy may be published as soon as this February 2007! :)
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