Start of Second Phase III Trial in MS Neuropathic Pain
Aug 9, 2006 - 2:45:37 PM
GW Pharmaceuticals plc (AIM: GWP) announces the start of a second pivotal Phase III trial in people with multiple sclerosis (MS) suffering from central neuropathic pain. The first patient has now been enrolled in the study.
This Phase III study is a double-blind randomised placebo-controlled study of Sativex in 218 patients with central neuropathic pain due to MS, who have achieved inadequate pain relief with existing therapies. This study therefore aims to address a currently unmet medical need and will be recruiting patients in the UK, Canada, France, Spain and the Czech Republic. The primary outcome measure in the study is the 0-10 Numeric Rating Scale pain score, as recommended by regulatory authorities in both Europe and North America. The study is expected to report headline results in about one year.
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.
It is regulatory convention for two pivotal Phase III trials in the same patient population to be required to support a product approval for a particular indication. This second pivotal Phase III study in MS Neuropathic Pain has a number of important roles in the regulatory strategy for Sativex, as follows:
* In Europe, this second pivotal study will complete a clinical data package to support a regulatory submission for Sativex in the indication of "MS Neuropathic Pain"
* In Europe, this study is intended to enhance the data package arising from GW's two ongoing peripheral neuropathic pain studies, to support a broad indication of "General Neuropathic Pain" as identified in recent EU guidelines
* In Canada, this study is intended to meet the conditions associated with the approval of Sativex in order to obtain a full Notice of Compliance.
Sativex is already approved in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in MS. Canada was the first country in the world to approve Sativex. Health Canada approved Sativex under the Notice of Compliance with Conditions policy.
Dr Stephen Wright, R&D Director, said, "GW has in place a broad regulatory strategy to support the global approval of Sativex across multiple related indications including neuropathic pain and spasticity in multiple sclerosis, peripheral neuropathic pain and cancer pain. One of the principal purposes of this study is to complete the regulatory package required for the approval in Europe of Sativex in the indication of neuropathic pain in MS.
"Neuropathic pain is a debilitating symptom of MS and is often under treated and inadequately controlled. Our data show that Sativex has a valuable role to play in treating this significant unmet medical need."
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