GW, Otsuka Begin Sativex Trial

UK’s GW Pharmaceuticals and Japan’s Otsuka Pharmaceutical have started the first U.S. Phase II/III dose-ranging trial to evaluate the efficacy and safety of Sativex for the treatment of pain in patients with advanced cancer.

The five-week, placebo-controlled study will recruit 336 patients with advanced cancer for which there is no known curative therapy.

The primary objective of the study is to evaluate the role and dose range of Sativex in these patients as an adjunct to their pre-existing pain medications. The primary endpoint of the study will be the response rate for patients at the end of five weeks of therapy, GW said.

Sativex is an investigational new product composed primarily of two cannabinoids: cannabidiol and delta 9 tetrahydrocannabinol.