Canada approves GW's cannabis drug for multiple sclerosis sufferers

April 19, 2005

Stephen Foley, The Independent (UK)

GW Pharmaceuticals has become the first drug company to gain approval to launch a cannabis-based medicine for multiple sclerosis sufferers.

The approval in Canada comes after six years of work for the company, which grows cannabis at a secret farm in southern England and turns it into an under-the-tongue spray, Sativex. And it marks a breakthrough for MS sufferers, who have long argued that cannabis relieves its symptoms, including pain and spasticity.

The Canadian authorities will allow GW - through its marketing partner, the German drug giant Bayer - to sell Sativex as a prescription painkiller, provided the company does additional clinical trials of the medicine over the next five years. GW must confirm the results of the studies to date, which have been promising, Health Canada said. The drug has so far been turned down by regulators in the UK, who say GW has not proven to their satisfaction that Sativex is effective.

Bayer will pay GW a £2m milestone as a result of Health Canada's approval. Launch batches of Sativex are already in the country, and the drug will be available within weeks. Analysts disagree on the likely sales potential in Canada, which has 50,000 MS sufferers, half of whom suffer from the neuropathic pain Sativex has been approved to treat. Smoked cannabis is also available in Canada for medicinal use, and proposals for its decriminalisation are being debated.

Karl Keegan, an analyst at Canaccord, said: 'I think initially there will be a lot of hype over Sativex, but I suspect that people will want to smoke cannabis rather than use a mouth spray.'

How Sativex is seen

• Canada: Health Canada has become the first regulator to approve a prescription medicine based on cannabis. Because so few MS sufferers say their pain can be treated effectively with existing medicines, it accelerated the approval process.

• UK: GW has faced several setbacks in its dealings with the UK, despite the Home Office's backing for its plans to develop a cannabis-based MS treatment. The independent medicines regulator argued there was not enough data to support its launch as a painkiller. GW is appealing the ruling at a hearing this summer.

• Europe: European regulators will take their cue from the UK, so analysts believe that Sativex's full commercial potential can only be unlocked when GW has satisfied the regulator in its home country.

• US: Originally thought opposed to cannabis-based medicines because it would represent weakness in its war on drugs. Now, though, GW believes regulators might be won round and will open talks this summer on how it might be allowed to trial Sativex in the US.


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