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GW wins U.S. okay for pivotal cannabis drug study
By Ben Hirschler | Scotsman.com | Wed 4 Jan 2006

LONDON (Reuters) - GW Pharmaceuticals 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 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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This article: http://business.scotsman.com/latest.cfm?id=12922006

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Buzzby

It'll be interesting if the FDA approves Sativex. People will be able to buy it at the drugstore but it would be illegal to manufacture here because nobody is allowed to grow marijuana. It would be a legal drug the raw materials for which would be illegal.

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MrIMStoned

Yeah, and it had nothing to do with people being afraid to even possess marijuana for fear of imprisonment.

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"In the end the Party would announce that two and two made five, and you would have to believe it. It was inevitable that they should make that claim sooner or later: the logic of their position demanded it. Not merely the validity of experience, but the very existence of external reality, was tacitly denied by their philosophy. The heresy of heresies was common sense. And what was terrifying was not that they would kill you for thinking otherwise, but that they might be right. For, after all, how do we know that two and two make four? Or that the force of gravity works? Or that the past is unchangeable? If both the past and the external world exist only in the mind, and if the mind itself is controllable what then?"

Buzzby

You're right. It had nothing to do with that because this was before it became illegal to possess marijuana.

Morphine was in general use by the time of the American Civil War and heroin was synthesized from morphine in 1874. The Marijuana Tax Stamp Act wasn't passed until 1937.