GW's Sativex goes straight to Ph III in USA
The UK's GW Pharmaceuticals says that its cannabis-based painkiller Sativex will directly enter Phase III trials in the USA for cancer-associated pain.
The US Food and Drug Administration has accepted GW's Investigational New Drug application for the drug, which is primarily composed of tetrahydrocannabinol and cannabidiol, for the treatment of pain in patients with advanced cancer that has been poorly relieved by opioids.
The 250-patient, double-blind, randomized, placebo-controlled study will evaluate the effect of the agent in relieving average daily pain, reducing the use of breakthrough opioid medications, improving the quality of sleep and relevant aspects of quality of life among other outcome measures.
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