Health Canada has approved Sativex (Cannabis sativa L. extract) a new drug developed as adjunctive treatment for the symptomatic relief of neuropathic pain in adults with multiple sclerosis (MS).
Canada becomes the first country in the world to approve Sativex, a novel prescription pharmaceutical product derived from components of the cannabis plant shown to have therapeutic properties. Sativex is administered via a spray into the mouth.
Health Canada has approved Sativex with conditions, under the Notice of Compliance with Conditions (NOC/c) policy. This authorization reflects the promising nature of the clinical evidence which will be confirmed with further studies. Products approved under Health Canada’s NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use.
“Effective pain control and management are extremely important in a disease like MS,” said Dr. Allan Gordon, Neurologist and Director of the Wasser Pain Management Centre, Mount Sinai Hospital, Toronto, Ontario. “The approval of Sativex in Canada reflects the urgent need for additional treatment options in the field of neuropathic pain in MS.”
Pain is a common symptom of MS occurring in up to 86 per cent of people with MS. Neuropathic or nerve pain can occur spontaneously or can be provoked by touch, temperature or movement. It is estimated that 50 per cent of people with MS suffer from chronic neuropathic pain. The most common descriptions of neuropathic pain are of freezing, cold or burning sensations usually of the limbs and most often of the lower extremities. Many individuals with neuropathic pain respond inadequately to current treatment options.
“It’s hard to explain to someone who has never felt this type of pain. It’s like being plugged into an electric socket all the time,” said Steve Walsh, who suffers from MS and has lived with neuropathic pain for five years. “At times, putting on clothes or anything touching me can be too much to take,” he added.
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