Lord Mong
New Member
The Multiple Sclerosis Trust reacted angrily yesterday to news that the Medical Regulatory Healthcare Agency, the UK's drug watchdog, is demanding more tests on a treatment for the condition derived from cannabis.
Savitex, an oral spray developed by the drugs company GW Pharmaceuticals, is now unlikely to gain regulatory approval in this country until 2009 despite recently winning full regulatory approval in Canada.
GW Pharmaceuticals said yesterday that it had withdrawn its application for regulatory approval in the UK and Europe pending further tests in order to satisfy the MRHA.
In a blunt statement, Professor Mike Barnes, a trustee of the MS Trust and one of the UK's leading neurological rehabilitation experts, claimed that the evidence of Savitex's efficacy was already"compelling". He said: "It [the research data] showed that, on average, half of the people with MS who tried Sativex gained some benefit. There were no safety concerns. Despite this the MHRA has asked for yet more data ... it is our view that Sativex should be licensed and become available ... for patients with spasticity due to multiple sclerosis."
GW Pharma expects new data to be compiled within 12 months and plans to re-submit its application for approval as soon as the research is completed. It will recruit 200 new patients for the study, in addition to the 1,200 people that are already using the treatment on a named patient basis in the UK.
GW Pharma has had a licence to grow cannabis in the UK for nine years, and despite investing significant sums it is yet to make a profit. However, the company has recently signed a number of high-profile distribution deals for Savitex with major pharmaceutical groups, including Otsuka in the US, Bayer in the UK and Canada and Almirall in Europe.
Savitex has also been developed to treat cancer pain. A spokesman for the company said yesterday that the decision to withdraw its bid for regulatory approval "follows constructive and detailed discussions with regulatory authorities in which they have provided a clear path to approval for Sativex".
Campaigners for the licensing of cannabis-derived treatments for conditions such as MS have won some support from MPs, but medical authorities have so far proceeded cautiously.
Yesterday's announcement sent shares in GW Pharma to a new all-time low, 27p worse at 65p, a fall of more than 30 per cent.
Newshawk: Lord Mong - 420 MAGAZINE ® - Medical Marijuana Publication & Social Networking
Source: The Independant
Author: Andrew Dewson
Contact: news@independent.co.uk
Copyright: Copyright 2007
Website: GW Pharma forced to hold back on cannabis treatment - Independent Online Edition > Business News
Savitex, an oral spray developed by the drugs company GW Pharmaceuticals, is now unlikely to gain regulatory approval in this country until 2009 despite recently winning full regulatory approval in Canada.
GW Pharmaceuticals said yesterday that it had withdrawn its application for regulatory approval in the UK and Europe pending further tests in order to satisfy the MRHA.
In a blunt statement, Professor Mike Barnes, a trustee of the MS Trust and one of the UK's leading neurological rehabilitation experts, claimed that the evidence of Savitex's efficacy was already"compelling". He said: "It [the research data] showed that, on average, half of the people with MS who tried Sativex gained some benefit. There were no safety concerns. Despite this the MHRA has asked for yet more data ... it is our view that Sativex should be licensed and become available ... for patients with spasticity due to multiple sclerosis."
GW Pharma expects new data to be compiled within 12 months and plans to re-submit its application for approval as soon as the research is completed. It will recruit 200 new patients for the study, in addition to the 1,200 people that are already using the treatment on a named patient basis in the UK.
GW Pharma has had a licence to grow cannabis in the UK for nine years, and despite investing significant sums it is yet to make a profit. However, the company has recently signed a number of high-profile distribution deals for Savitex with major pharmaceutical groups, including Otsuka in the US, Bayer in the UK and Canada and Almirall in Europe.
Savitex has also been developed to treat cancer pain. A spokesman for the company said yesterday that the decision to withdraw its bid for regulatory approval "follows constructive and detailed discussions with regulatory authorities in which they have provided a clear path to approval for Sativex".
Campaigners for the licensing of cannabis-derived treatments for conditions such as MS have won some support from MPs, but medical authorities have so far proceeded cautiously.
Yesterday's announcement sent shares in GW Pharma to a new all-time low, 27p worse at 65p, a fall of more than 30 per cent.
Newshawk: Lord Mong - 420 MAGAZINE ® - Medical Marijuana Publication & Social Networking
Source: The Independant
Author: Andrew Dewson
Contact: news@independent.co.uk
Copyright: Copyright 2007
Website: GW Pharma forced to hold back on cannabis treatment - Independent Online Edition > Business News
