Sativex is a cannabis based medicine containing Tetranabinex and Nabidiolex extracts of chemically and genetically characterised Cannabis sativa L. plants. The principal active components are delta-9-tetrahydrocannabinol ( THC ) and cannabidiol (CBD ).

Health Canada has approved Sativex with conditions, under the Notice of Compliance with Conditions ( NOC/c ) policy.
This authorisation reflects the promising nature of the clinical evidence which must 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.

Sativex is used for the adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis in adults.

Sativex is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.
The exact mechanism of action in relieving neuropathic pain is not known.

Sativex causes irritations in the mouth in 20 - 25% patients in clinical trials.
Patients may also experience symptoms of cannabinoid intoxication, including dizziness when they first take Sativex.
Fainting episodes have been reported as well as feeling drunk, disturbance in attention, dizziness, somnolence, disorientation, dissociation and euphoric mood.
THC can cause symptoms such as changes of mood, decrease in cognitive performances and memory, decrease in ability to control drives and impulses, and alteration of the perception of reality, particularly altered time sense.

Patients should start from low doses and adjust their doses gradually to get the optimal balance of a good control on their neuropathic pain and minimal intoxication.

Sativex may impair ability to carry out complicated tasks. Patients should not drive or engage in activities requiring unimpaired judgment and coordination.

Sativex is contraindicated in:

- patients with known or suspected allergy to cannabinoids, propylene glycol, ethanol or peppermint oil

- patients with significant hepatic or renal impairment

- patients with serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure

- patients with a history of schizophrenia or any other psychotic disorder

- children under 18 years of age

- women of child-bearing potential not on a reliable contraceptive or men intending to start a family

- pregnant or nursing women.

Sativex is a solution supplied in small vials as a buccal spray.
The patient takes the spray, directed under the tongue or inside of the cheeks, cautiously establishing the best dose for reducing their pain through titration up to a tolerated dose.

Source: Health Canada, 2005


XagenaMedicine2005