GW Pharmaceuticals announced preliminary results of two Phase III studies of Sativex®, its cannabinoid spray medicine, in peripheral neuropathic pain.
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The results of the study in patients with neuropathic pain characterized 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.”
This multi-centre double-blind, randomized, 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.
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
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last call. More info at www.diabetes911.net
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