Sativex nabiximols: Phase III data
Top-line data from a double-blind, international Phase III trial in 399 patients with advanced cancer who experienced inadequate analgesia during optimized chronic opioid therapy showed that 3-10 daily sprays of Sativex over 5 weeks as an adjunct to optimized chronic opioid therapy missed the primary endpoint of improving pain as measured by an NRS from baseline to week 5 vs. placebo plus optimized chronic opioid therapy. Additionally, Sativex plus opioid therapy did not significantly improve pain when analyzed using a cumulative proportion of responders analysis vs. placebo plus opioid therapy. Sativex was well tolerated with neoplasm progression, somnolence and dizziness reported as the most common adverse events. The trial comprised a 5-14 day stabilization period at the beginning of the trial, a 5-week treatment period and a 1-week follow-up period. Data from 2 additional trials of Sativex in the indication are expected this year. ...