GW Pharmaceuticals plc (AIM: GWP) announces that patient recruitment is now complete in its pivotal Phase III trial in people with multiple sclerosis (MS) suffering from central neuropathic pain.
This Phase III study is a double-blind randomised placebo-controlled study of Sativex® in patients with central neuropathic pain due to MS, who have achieved inadequate pain relief with existing therapies. The study has recruited 339 patients in the UK, Canada, France, Spain and the Czech Republic and is GW's largest clinical trial to date.
The duration of treatment in the study is 14 weeks. The last patient will exit the study at the end of 2007 with headline results expected in H1 2008.
GW has previously carried out a similar pivotal Phase III study with positive results. This study, which was published in the peer–reviewed journal, Neurology, showed that Sativex was significantly superior to placebo in reducing pain (p=0.005) and sleep disturbance (p=0.003)1.
This second pivotal Phase III study in MS Neuropathic Pain has two potential roles in the regulatory strategy for Sativex, as follows:
In Europe, this study may provide a clinical data package to support a regulatory submission for Sativex in the indication of "MS Neuropathic Pain"
In Canada, this study is intended to meet the condition associated with the approval of Sativex in order to obtain a full Notice of Compliance
Dr Stephen Wright, R&D Director, said, "Neuropathic pain is a debilitating symptom of MS and is often under treated and inadequately controlled. Previous clinical trials and post–marketing experience in Canada show that Sativex has a valuable role to play in treating this significant unmet medical need. We look forward to the results of this confirmatory Phase III study."
Sativex is already approved in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in MS and in cancer pain. Health Canada approved Sativex under the Notice of Compliance with conditions (NOC/c) policy.