Pubdate: Wed, 06 Sep 2006
Source: BBC News (UK Web)
Copyright: 2006 BBC
Website: http://news.bbc.co.uk/
Cited: GW Pharmaceuticals http://www.gwpharm.com
Bookmark: http://www.mapinc.org/topics/Sativex
Bookmark: http://www.mapinc.org/find?323 (GW Pharmaceuticals)

CANNABIS DRUG FILED FOR APPROVAL

The first cannabis-based medication for MS has been filed for 
approval by British regulators.

GW Pharmaceuticals' Sativex, an under-the-tongue spray, can now be 
given on a named-patient basis.

But the company is applying to regulators across Europe for a licence 
to make it more widely available.

The company has been seeking a full UK licence for the spray since 
2003, but regulators said they wanted to see more information before 
issuing one.

Eighty-five thousand people in the UK have MS. It is not yet certain 
how many of them would benefit from Sativex.

The spray is intended to treat the muscle spasticity associated with 
the degenerative disease.

Positive Data

The drug is a mouth spray containing two chemicals found in cannabis, 
tetrahydrocannabinol and cannabidiol.

Sativex was first approved in Canada in April 2005. It received 
approval for use by individual MS patients in the UK the following month.

GW Pharmaceuticals has now filed licence applications in the UK, 
Denmark, Spain and the Netherlands.

Stephen Wright, a spokesman for the company, said he was confident 
about new data available on the drug.

He said: "We have a sizeable body of positive clinical data to 
support the efficacy and safety of Sativex in MS spasticity."

A spokesman for the MS Society said: "People with MS are sourcing raw 
cannabis of whatever quality from goodness knows where, and running 
goodness knows what risks.

"It is important that we do see properly tested, effective, 
cannabis-based drugs."
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MAP posted-by: Richard Lake