by Rathi Manohar on  March 24, 2011 at 10:59 PM Drug News
 Cannabis-Based Treatment Delayed
The first legally licensed cannabis-based treatment by the National Health Service in Britain has been stalled by authorities, creating a lot of unhappiness and disappointed criticism.

Although certain parts of England, especially the Coventry and Warwickshire areas in the Midlands, have come under a similar stricture, it is Scotland that seems to have expressed extreme disappointment over the delay. This is because Scotland has one of the highest rates of multiple sclerosis in the world, with the number of sufferers exceeding 10,000.

Multiple Sclerosis is an irreversible condition that progressively destroys the central nervous system. It usually affects young people in their 20s and 30s.

Spasticity, which builds up muscle stiffness and painful spasms are symptomatic to the illness and this can make daily actions extremely difficult.

Sativex, manufactured by Bayer HealthCare is a mouth spray that has cannabis extracts, and these help patients by easing their pain and gradual loss of mobility. In fact, the drug was manufactured when sufferers illegally resorted to using cannabis to relieve the excruciating pain they were going through.

The Scottish Medicines Consortium which has to give its approval has not done so as it had not received a formal application from the manufacturer.

Professor Ken Paterson, chairman of the SMC, said: "We are disappointed we haven't received a submission from the manufacturer, especially when there appears to be some interest within the medical community to find out if this medicine is cost-effective.

"We are heartened to learn the manufacturer is actively working on a submission and we look forward to receiving it at their earliest convenience. Until the submission arrives, we are not in a position to recommend it."

Dr Jayne Spink, director of policy and research for the MS Society, has reported that although Sativex has been through rigorous clinical trials and had gone through all the regulatory processes and had received the license to treat symptoms of spasticity in people with MS who have not responded adequately to other medication, patients in UK are still struggling to get it.

Bayer HealthCare says, "As our clinical trials were designed to add Sativex into patients' existing treatment regimens, and for the specific purpose of achieving regulatory approval, we do not yet have the requisite data comparing the costs and clinical effectiveness of Sativex to existing treatments for spasticity in MS."

Till the company collects its information, it will not present its application to the SMC. And patients have expressed their deep unhappiness over this situation.

Source: Medindia

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