GW Pharmaceuticals Completes Patient Recruitment in Sativex Trial
GW Pharmaceuticals announced that patient recruitment is now complete in its pivotal Phase III Sativex trial in people with multiple sclerosis suffering from central neuropathic pain.
The 14-week, double-blind, randomized, placebo-controlled Phase III study of Sativex has enrolled patients who have achieved inadequate pain relief with existing therapies, GW Pharmaceuticals said.
The study recruited 339 patients in the UK, Canada, France, Spain and the Czech Republic and is company’s largest clinical trial to date.
GW has previously carried out a similar pivotal Phase III study, which was published in the peer–reviewed journal, Neurology. The article reported that that Sativex was superior to placebo in reducing pain and sleep disturbance.
With the second Phase III study, the company said it hopes to provide a clinical data package to support a regulatory submission in Europe and obtain a notice of compliance in Canada.