Health Canada has issued a conditional marketing authorisation under the Notice of Compliance with Conditions ( NOC/c ) policy for Sativex, a cannabis based medicine, as adjunctive treatment for the symptomatic relief of neuropathic pain in patients with multiple sclerosis in adults.
This authorization reflects the promising nature of the clinical evidence and the need for confirmatory studies to verify the clinical benefit.

Sativex ( Cannabis sativa L. extract ) is 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.

Pain is a common symptom of multiple sclerosis occurring in up to 86 per cent of people with multiple sclerosis.
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 multiple sclerosis 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.

A double-blind placebo controlled parallel group study showed that Sativex provides significantly greater pain relief than placebo.
Sativex also significantly reduced pain-related sleep disturbance.

Sativex is the first product indicated in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis.
Its principal active cannabinoid components are delta-9-tetrahydrocannabinol ( THC ) and cannabidiol ( CBD ).
The ratio of THC to CBD in Sativex is 2.7 mg : 2.5 mg per spray.

Sativex is administered through a spray pump under the tongue or on the inside of the cheek, providing reliable, self-administered pain relief.

In clinical trials, the most frequent side-effects included nausea, fatigue, dizziness and application site reactions.
Side-effects were usually mild or moderate in severity and often resolved with down-titration or interruption of treatment.

Source: Health Canada, 2005


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