Cannabis-based drug is cleared for use by multiple sclerosis sufferers

David Winning
Wednesday 16 November 2005 01:00 GMT
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People with multiple sclerosis can be prescribed a new cannabis-based med-icine even though it is yet to be licensed in the UK.

The Home Office has agreed to requests from doctors and patients to allow Sativex to be imported from Canada, where it has been on sale since late June.

The decision by Paul Goggins, the Home Office minister with responsibility for drugs, was made in spite of the refusal of regulators last year to award Sativex a full licence in the UK until more clinical data was available.

A statement from the drug's manufacturer, GW Pharmaceuticals, said there was scope within the Medicines Act for a drug to be prescribed and supplied in response to a specific request from a GP even if it had not yet been licensed. "The basis on which Sativex may be imported, therefore, is the clinical judgement of doctors in relation to specific, nominated patients," GW said.

Doctors will need a special Home Office licence to prescribe Sativex - an oral spray designed to relieve spasticity, or involuntary muscle contractions, in MS sufferers. Because it will remain a controlled drug, GW said that talks would take place with the Home Office during the coming weeks over how a licensing regime can be put in place.

After the Home Office agreement was made known yesterday, shares in GW rose by 20 per cent. The company also confirmed that it still intended to seek full regulatory approval for Sativex in the UK.

The company is conducting further trials and is planning to submit a fresh marketing application to the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2006. Only after such an approval is granted can the product be promoted in the UK.

A spokeswoman for the Department of Health said: "Last year the MHRA refused a licence for Sativex for the treatment of patients with MS. Sativex is therefore not licensed in the UK but a clinician may prescribe the drug for unlicensed use for named patients in exceptional cases. A clinician who wishes to prescribe Sativex on the NHS will need to get the decision ratified by the appropriate NHS trust and/or primary care trust."

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