GW Pharma progresses Ph III cannabis spray MS trial

The UK's GW Pharmaceuticals has completed patient recruitment in its Phase III multiple sclerosis spasticity trial of cannabis mouth spray Sativex. The 575-patient study in 52 hospital sites in the UK, Spain, Italy, the Czech Republic and Poland, is the largest the firm has undertaken so far. The trial follows an "enriched design" format that first identifies responders over a four-week phase A period and then focuses on its effect versus placebo over 12 weeks in phase B. 255 patients are expected to enter the second stage, exceeding the target number of 244. The primary endpoint of the study is the difference in the severity of spasticity between Sativex and placebo groups in Phase B as assessed by the validated Numeric Rating Scale.