MHRA rejects Sativex licence application appeal
The MHRA announced today that it has turned down an appeal by GW Pharmaceuticals on their licence application for Sativex (oral cannabis spray) for the treatment of spasticity in people with multiple sclerosis. The reason given is that the data available so far do not provide sufficient evidence of effectiveness. Although there was no particular concern on toxicity, the preparation was not shown to have a favourable risk to benefit relationship as a result. The company has already started a further clinical trial to try and gain the necessary efficacy data, and this is expected to finish in Spring 2006.
MHRA media release
GW Pharmaceuticals media release
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