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UK: MS treatment made from cannabis hits trial setback

David Teather

The Guardian

Saturday 18 Mar 2006

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The developer of a cannabis-based treatment for multiple sclerosis
reported disappointing results in late-stage testing yesterday, sending
shares in the company, GW Pharmaceuticals, down 25%.

The firm grows thousands of marijuana plants at a secret location in the
English countryside under a special dispensation from the government.

The treatment, Sativex, is already on sale in Canada to treat nerve pain
but the company is facing a longer wait than expected for approval in
Britain. Regulators in this country asked for additional data from the
company last June.

Many people with MS have used cannabis illegally to relieve their
symptoms, including spasticity - muscle tightness and stiffness - and
nerve pain. An estimated 85,000 people in Britain suffer from the disease.

The company said that patients in the latest tests who used the
under-the-tongue spray and stuck to the trial protocols - using the
treatment as directed - did benefit. The trial had focused on the
treatment of spasticity. But a wider analysis that included all of the
patients, whether they stuck to the protocols or not, found no
statistically significant advantage when compared with a placebo. The
results mean that GW may now delay filing for regulatory approval in Europe.

"We need to pause for breath from a regulatory perspective and decide
whether to go full steam ahead with a filing for this indication or
whether it makes more sense strategically for us to wait for results of
the [neuropathic] pain studies before filing," said the managing
director, Justin Glover.

The company said it remained hopeful, especially about the treatment of
neuropathic pain, caused by nerve damage.

"Most consistently positive data we have seen previously has been in
neuropathic pain, so we are certainly quietly optimistic," said the
research and development director, Stephen Wright.

The company's shares closed down 32p yesterday at 94.5p.

 

 

 

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