 | NORML News: Canada approves Sativex for cancer pain |
GW 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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