In February 2007, GW and Otsuka Pharmaceutical announced an exclusive agreement for Otsuka to develop and market Sativex in the United States. Sativex has received permission from the US regulatory authority, the FDA, to enter directly into late stage Phase III trials in the US. The first large scale US trial, Spray Trial, for cancer patients is underway and due to complete at the end of 2009.
The 336-patient, double-blind, randomized, placebo-controlled study is evaluating the effect of Sativex 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.
The 336-patient, double-blind, randomized, placebo-controlled study is evaluating the effect of Sativex 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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