Canada: approval for Sativex

The cannabis extract Sativex of the British firm GW Pharmaceuticals received Qualifying Notice for approval by the Canadian health ministry (Health Canada). Sativex will initially be indicated in Canada for the relief of neuropathic pain in multiple sclerosis.

The news comes just weeks after British regulators said they wanted more evidence about the benefits of the drug. In the UK the firm had applied for a different indication, for the treatment of spasticity in patients with multiple sclerosis.

Sativex is a whole plant cannabis extract containing the cannabinoids THC and CBD as its principal components. The medicine is administered by means of a spray into the mouth. It will be exclusively marketed in Canada by Bayer HealthCare. Health Canada has confirmed that Sativex qualifies to be considered for approval. GW is required to respond and accept conditions within 30 days. If the response is acceptable, the regulator will proceed to finalize the marketing authorization.

Analysts said the Canadian system for drug approval meant the rest of the process was little more than a formality. GW said it expected full approval by early next year.

(Sources: Reuters of 21 December 2004, press release of GW Pharmaceuticals of 21 December 2004)