|GW Pharma has started a second pivotal phase III trial of Sativex in people with multiple sclerosis suffering from central neuropathic pain, it said today, but the shares slipped back following recent gains.|
The cannabis-based medicines group said the study aims to address a currently unmet medical need and will be recruiting patients in the UK, Canada, France, Spain and the Czech Republic.
The first patient has now been enrolled in the study which is expected to report headline results in about a year.
A previous pivotal phase III trial showed that Sativex was significantly superior to placebo in reducing pain and sleep disturbance.
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.
Canada was the first country to approve Sativex as adjunctive treatment for the symptomatic relief of neuropathic pain in MS.