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UK: Cannabis drugs pass testing 'milestone'

Emma Young

New Scientist

Tuesday 05 Nov 2002

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Cannabis-based drugs could be prescribed in the UK as early as 2003,
following successful final-stage trials in patients with multiple sclerosis.

Compared with standard treatments alone, the drugs significantly improved
symptoms of MS and reduced pain caused by other types of nerve damage, GW
Pharmaceuticals has announced. The company is the sole UK holder of a
licence to cultivate and supply cannabis for medical research.

"These results represent a milestone in the pharmaceutical development of
cannabis-based medicines," says Geoffrey Guy, GW's executive chairman.
"Subject to regulatory approval, we are now on track to deliver our first
prescription medicine to the UK market next year."

Existing legislation would have to be altered to permit doctors to
prescribe cannabis-based medicines. But the UK government has said it would
make these legal changes if large-scale trials showed the medicines offered
a "clear benefit".

Other research groups around the world are testing cannabis-based drugs.
But the GW results are from the most advanced large-scale trials.


Psychoactive effects


On Tuesday, GW announced the results of four randomised, double-blind Phase
III trials. Phase III trials are normally the final round before the
creators of a new drug seek regulatory approval.

The GW trials investigated the effectiveness of a "whole plant medicinal
cannabis extract", containing active ingredients tetrahydrocannabinol (THC)
and cannabidiol (CBD) as its principal components. The drug was delivered
as a spray into the mouth.

Throughout the trials, patients receiving either the treatment or a placebo
continued to take their regular prescribed medications.

The trials on about 350 patients showed significant reductions in
spasticity and pain and improvements in sleep in people with MS. Patients
with another type of nerve damage also reported a reduction in pain. No
serious psychoactive effects were reported.


Illegal use


The UK's Multiple Sclerosis Society said the results are "very
encouraging". An estimated 10 per cent of the UK's MS sufferers use
cannabis illegally to help combat symptoms. GW has another five cannabis
trials in progress. These are investigating other uses of the drug, for
treating pain in cancer and spinal cord injury, for example. The results of
these trials are due in 2003.

However, the results of previous trials in Europe have suggested that
cannabis-based drugs are no better than existing treatments for cancer pain
and have more serious side effects.

In May 2001, the US Supreme Court ruled that cannabis could not be legally
used as medicine. If cannabis-based drugs are given the all-clear in the
UK, analysts expect that the rest of Europe and Canada will be next to
grant approval, within about six to nine months. But the US might not
follow for at least two years, due to stricter tests required by its Food
and Drug Administration.

 

 

 

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