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UK: Cannabis drug filed for approval

BBC Online

Wednesday 06 Sep 2006

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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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