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 NORML News: Canada approves Sativex for cancer pain

Medical MarijuanaGW Pharmaceuticals and Bayer HealthCare have announced the Canadian Health Ministry has approved their cannabis extract Sativex for the relief of cancer pain.

Sativex is already approved and marketed in Canada for the relief of neuropathic pain in multiple sclerosis. The latest approval is for “adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain”.

Sativex, an under-the-tongue spray, has been developed by UK-based GW Pharmaceuticals - which has a dispensation from the British government to grow cannabis for medical research - and is marketed outside Europe and the United States by Bayer.

GW just completed a positive Phase III study in Europe in 177 patients with cancer pain. The trial was a multi-centre double-blind, placebo-controlled study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication.

The company recently signed a deal with Japan’s Otsuka Pharmaceutical Co to research and develop cannabis-based treatments for cancer and central-nervous-system disorders.

The agreement is initially for three years, during which Otsuka would make US$9 million available for research. Otsuka has also bought the rights to develop and market Sativex in the United States. Sativex is currently being assessed for approval in Europe.

Meanwhile, the latest figures from Health Canada show it has authorised 1,742 patients to possess cannabis as a medication. Of these, 1,040 are licensed to grow their own, and another 167 people are licensed to grow cannabis for patients. Health Canada appears to be making a tidy profit on the scheme. It buys cannabis from a licensed grower for C$328.75 a kilogram and sells it to patients for about C$5,000 a kilogram.

  • Sources: Canadian Press 17 April 2007; Belle-Isle L, Hathaway A., AIDS Care 2007;19(4):500-6. G W Pharmaceuticals





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