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Cannabis Plant On Which New Medicine Is Based
Doctors are set to prescribe a new cannabis-based medicine to patients with multiple sclerosis 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 drugs minister Paul Goggins 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 maker 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 has 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 for the relief of spasticity, or involuntary muscle contractions, in MS sufferers.
Because it will remain a controlled drug, GW said talks will take place with the Home Office during the coming weeks over how a licensing regime can be put in place.
Today's news sent shares in GW up 20 per cent and the company confirmed it still intended to seek full regulatory approval for Sativex in the UK.
The company is conducting a number of further Phase III trials and is planning to submit a fresh marketing application to the Medicines and Healthcare products Regulatory Agency ( MHRA ) during 2006.
Only after such an approval is granted can the product be promoted in the UK.
Source: Daily Mail (UK)
Copyright: 2005 Associated Newspapers Ltd
Contact: letters@dailymail.co.uk
Website: Home | Daily Mail Online
Doctors are set to prescribe a new cannabis-based medicine to patients with multiple sclerosis 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 drugs minister Paul Goggins 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 maker 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 has 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 for the relief of spasticity, or involuntary muscle contractions, in MS sufferers.
Because it will remain a controlled drug, GW said talks will take place with the Home Office during the coming weeks over how a licensing regime can be put in place.
Today's news sent shares in GW up 20 per cent and the company confirmed it still intended to seek full regulatory approval for Sativex in the UK.
The company is conducting a number of further Phase III trials and is planning to submit a fresh marketing application to the Medicines and Healthcare products Regulatory Agency ( MHRA ) during 2006.
Only after such an approval is granted can the product be promoted in the UK.
Source: Daily Mail (UK)
Copyright: 2005 Associated Newspapers Ltd
Contact: letters@dailymail.co.uk
Website: Home | Daily Mail Online
