GW INITIATES SECOND PHASE III TRIAL OF MS PAIN DRUG

GW Pharmaceuticals has begun a second Phase III trial in people with multiple sclerosis (MS) suffering from central neuropathic pain. The first patient has been enrolled in the study.

This trial is a double-blind, randomized, 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 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 zero to 10 Numeric Rating Scale pain score, as recommended by regulatory authorities in both Europe and North America.

GW has previously carried out a similar 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 and sleep disturbance.