BioCentury
ARTICLE | Clinical News

Sativex: Phase III started

May 28, 2012 7:00 AM UTC

GW and partner Otsuka began a 2-part Phase III trial to evaluate twice-daily Sativex for up to 10 sprays per day in patients with advanced cancer who have inadequate analgesia even with optimized chronic opioid therapy. The single-blind first part will evaluate Sativex for 2 weeks in about 540 patients. In the double-blind second part, patients who respond to treatment will be randomized to receive Sativex or placebo for 5 additional weeks. This is the third Phase III trial of Sativex to treat cancer pain and it will provide supportive data for the first 2 trials, which are slated to complete enrollment by the end of 2013. ...