Pubdate: Wed, 04 Jan 2006
Source: Scotsman (UK)
Copyright: The Scotsman Publications Ltd 2006
Contact:  http://www.scotsman.com/
Details: http://www.mapinc.org/media/406
Author: Ben Hirschler
Cited: GW Pharmaceuticals http://www.gwpharm.com/
Bookmark: http://www.mapinc.org/find?323 (GW Pharmaceuticals)
Bookmark: http://www.mapinc.org/topics/Sativex
Bookmark: http://www.mapinc.org/mmj.htm (Cannabis - Medicinal)
Bookmark: http://www.mapinc.org/find?232 (Chronic Pain)

GW WINS U.S. OKAY FOR PIVOTAL CANNABIS DRUG STUDY

LONDON (Reuters) - GW Pharmaceuticals Plc has won approval from U.S.
regulators to conduct a pivotal Phase III study into its
cannabis-based medicine Sativex as a treatment for cancer pain, the
drug company said on Wednesday.

GW expects to start testing the product, which is sprayed into the
mouth, in U.S. patients with advanced cancer later this year.

The randomised clinical trial will involve 250 people and is likely to
last between 24 and 36 months, suggesting Sativex will not be ready
for launch in the U.S. marketplace until towards the end of the decade.

Canada became the first country in the world to approve Sativex in
April 2005, for the relief of neuropathic pain in patients with
multiple sclerosis.

GW suffered a setback three weeks ago, however, when a British inquest
found the death of a patient taking Sativex in an earlier clinical
study was probably linked to the medicine.

Sativex is GW's leading product and the source of most of the
company's value.

The group grows thousands of marijuana plants at a secret location in
the English countryside, having been granted a dispensation by the
government to use the plant for medical research.

Geoffrey Guy, GW's executive chairman, said the acceptance of the
Phase III study application by the Food and Drug Administration was a
significant achievement for the company that would compress the
overall length of time needed to win U.S. approval by avoiding the
need for earlier-stage trials.

Having the product in final tests should also strengthen GW's hand in
negotiations with potential partners in the United States, where it
has yet to sign up a marketing ally.

Germany's Bayer AG is GW's marketing partner in Canada and Britain,
while Almirall of Spain recently agreed to market the drug in European
countries excluding Britain.

Cannabis has a long history of medicinal use, dating back to ancient
Chinese times. Queen Victoria, whose physician described it as "one of
the most valuable medicines we possess", is said to have taken
cannabis tincture for her menstrual pains.

It fell out of favour in the 20th century because of a lack of
standardised preparations and the development of more potent synthetic
painkillers.

GW says it has got round those standardisation problems with its
spray-based product, which also avoids the damaging effects of smoking
the drug. 
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MAP posted-by: Richard Lake