Approval for cannabis spray sought in Canada

May 12, 2004

ROD MICKLEBURGH, Globe and Mail

The world's first proposed cannabis-laced prescription drug to relieve pain may get its start in Canada.

Pharmaceutical giant Bayer announced yesterday that it has applied to Health Canada for permission to market the drug Sativex to those who suffer from multiple sclerosis and severe neuropathic pain.

The application was made in conjunction with the developers of the drug, the pioneering British firm GW Pharmaceuticals, which has been growing about 40,000 pot plants a year at a secret location in a government-approved research project.

Sativex is a medicinal mouth spray developed from the major components of marijuana, including tetrahydrocannabinol (THC) and cannabidiol (CBD).

It would be the first prescription drug that uses real marijuana extracts and not a synthesized form, according to its proponents.

However, GW executive chairman Geoffrey Guy has said the cannabis-derived spray will not get patients high since it is sprayed under the tongue, rather than smoked or swallowed. 'They see the benefit without getting stoned.'

Early trials of the drug in Britain showed that it was a safe and effective treatment to relieve painful symptoms of multiple sclerosis.

Said one satisfied user: 'You never get that buzz [marijuana high]. You just notice your legs moving a bit freer. It certainly has changed my life.'

But the company's hopes to secure regulatory approval for Sativex in Britain have hit a number of snags since making its groundbreaking application in March, 2003.

Two weeks ago, the company announced that it did not expect British regulators to approve the drug for use by multiple-sclerosis patients until much later in the year. So, in the meantime, Canada has been asked for permission to market the drug.

'We are very pleased to be working in partnership with GW to bring this innovative medicine to the Canadian market, once it has been approved,' Bayer Inc. president Philip Blake said in a statement.

'MS patients often suffer from pain associated with this disease. We hope that Sativex offers another treatment option.'

Dr. Guy said his company has been involved in earlier 'positive and active' discussions with Health Canada officials about introducing the cannabis drug to Canadian patients.

'Subject to regulatory approval, we now look forward to bringing a non-smoked, cannabis-based prescription medicine to market in Canada.'

About 50,000 Canadians have multiple sclerosis. At least half of them suffer significant pain, according to the drug companies' statement.

Britain gave permission to GW to grow cannabis for research purposes in 1998, after the embarrassment of having many MS patients arrested by police for smoking marijuana to relieve their pain.

A spokesman for Health Canada said that 18 months are normally required to review and rule on a submission.

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