Health Canada approves cannabis-based drug for treatment of MS-related pain

April 19, 2005

Canadian Press, Canada.com

Drug regulators in this country have given market approval to a cannabis-based drug that can be used for relief of neuropathic pain in adults with multiple sclerosis.

GW Pharmaceuticals and Bayer HealthCare announced Tuesday that Health Canada has approved Sativex, a drug derived from components of the cannabis plant that is administered via a mouth spray. Canada is the first country in the world to approve the drug, developed by GW Pharmaceuticals and marketed in this country by pharmaceutical giant Bayer.

'Effective pain control and management are extremely important in a disease like MS,' pain expert Dr. Allan Gordon said in a release issued by the companies.

'The approval of Sativex in Canada reflects the urgent need for additional treatment options in the field of neuropathic pain in MS,' added Gordon, a neurologist and director of the Wasser Pain Management Centre at Toronto's Mount Sinai Hospital.

Pain management is a challenge with MS patients, of which there are an estimated 50,000 in Canada.

Neuropathic or nerve pain can occur spontaneously or can be triggered by touch, temperature or movement. It's estimated that about half of people with MS suffer from chronic neuropathic pain.

While there is no cure for the pain caused by the disease, a double-blind study - in which neither participants nor the researchers knew who was getting which treatment - showed Sativex provided 'significantly' greater pain relief than placebo, the release said.

The companies describe the product as a whole plant medicinal cannabis extract containing tetrahydrocannabinol, or THC, and cannabidiol as its principal components.

Side-effects can include nausea, fatigue, dizziness and application site reactions. In clinical trials side-effects were usually mild or moderate in severity and were often resolved with administration of lower doses or interruption of treatment.

The companies said Sativex is expected to be available through pharmacies by late spring.



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