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Sativex Shows Significant Spasticity Improvement, UK
GW Pharmaceuticals has announced plans to submit an application to market its cannabis-based multiple sclerosis (MS) treatment, Sativex, in the UK.
This follows the announcement this week of study results, which showed that in nearly three-quarters of people with MS taking a fixed dose of Sativex, there was an improvement of more than 30% in levels of spasticity.
The Phase III study investigated 573 people with MS who were affected by spasticity and had not responded to existing therapies.
Spasticity is one of the most common symptoms in MS. There are several treatments available for those who are affected by spasticity, but for some, these are ineffective.
Dr Lee Dunster, Head of Research at the MS Society, said: "We have been monitoring Sativex for many months now and are pleased with these positive results.
"Making Sativex widely available could help alleviate one of the most distressing symptoms of MS and this is especially good news for people with progressive forms of the condition."
Source:
Details:
A phase III trial of the cannabis-based treatment Sativex shows a significant improvement in spasticity in people with MS.
GW Pharmaceuticals has announced plans to submit an application in the UK to market its cannabis-based treatment, Sativex.
This announcement comes on the back of results of a Phase III study released yesterday, which reported that in 74% of people with multiple sclerosis (MS) taking a fixed dose of Sativex, there was an improvement of more than 30% in levels of spasticity.
The Phase III study involved 573 people with MS who were affected by spasticity and had not responded to existing therapies. Participants in the study were given an initial fixed dose of Sativex for four weeks. Those who responded to the treatment (241 of the original 573 people) continued to be given either Sativex or a placebo, for a further 12 weeks.
Results of the study showed that 74% of people who continued treatment with Sativex achieved an improvement of greater than 30% in their spasticity score compared with 51% of people who were given the placebo treatment. There were also significant reductions in spasms and sleep disturbances and an improvement in the overall impression of change in the study participants and doctors examining them.
The study also reported a reduction in side-effects associated with Sativex, which may have been due to the fixed dosage during the course of the trial.
Spasticity is one of the most common symptoms in MS, occurring in up to 75% of people. There are several treatments available for those who are affected by spasticity, but this Phase III study showed efficacy in people who had not responded, or only partially responded, to current remedies.
Although Sativex can help with symptoms associated with MS, it does not alter the course of the condition.
In February, GW Pharmaceuticals released results of a smaller withdrawal study showing that Sativex is safe and effective in people who had been on it for several years. More details of that study can be found here.
Sativex can currently be prescribed to people with MS by a GP on a named patient basis. This means that if a particular GP sees a need for Sativex he or she can prescribe it a patient but it is not widely available to people affected by MS. If GW Pharmaceuticals are successful in their application to the Medicines and Healthcare Regulatory Authority (MHRA), Sativex could be marketed in the UK as early as 2010.
This would represent the first hurdle in allowing Sativex to be widely available to people with MS. Sativex would still be subject to recommendation by the National Institutes of Health and Clinical Excellence (NICE).
Source:
GW Pharmaceuticals has announced plans to submit an application to market its cannabis-based multiple sclerosis (MS) treatment, Sativex, in the UK.
This follows the announcement this week of study results, which showed that in nearly three-quarters of people with MS taking a fixed dose of Sativex, there was an improvement of more than 30% in levels of spasticity.
The Phase III study investigated 573 people with MS who were affected by spasticity and had not responded to existing therapies.
Spasticity is one of the most common symptoms in MS. There are several treatments available for those who are affected by spasticity, but for some, these are ineffective.
Dr Lee Dunster, Head of Research at the MS Society, said: "We have been monitoring Sativex for many months now and are pleased with these positive results.
"Making Sativex widely available could help alleviate one of the most distressing symptoms of MS and this is especially good news for people with progressive forms of the condition."
Source:
Details:
A phase III trial of the cannabis-based treatment Sativex shows a significant improvement in spasticity in people with MS.
GW Pharmaceuticals has announced plans to submit an application in the UK to market its cannabis-based treatment, Sativex.
This announcement comes on the back of results of a Phase III study released yesterday, which reported that in 74% of people with multiple sclerosis (MS) taking a fixed dose of Sativex, there was an improvement of more than 30% in levels of spasticity.
The Phase III study involved 573 people with MS who were affected by spasticity and had not responded to existing therapies. Participants in the study were given an initial fixed dose of Sativex for four weeks. Those who responded to the treatment (241 of the original 573 people) continued to be given either Sativex or a placebo, for a further 12 weeks.
Results of the study showed that 74% of people who continued treatment with Sativex achieved an improvement of greater than 30% in their spasticity score compared with 51% of people who were given the placebo treatment. There were also significant reductions in spasms and sleep disturbances and an improvement in the overall impression of change in the study participants and doctors examining them.
The study also reported a reduction in side-effects associated with Sativex, which may have been due to the fixed dosage during the course of the trial.
Spasticity is one of the most common symptoms in MS, occurring in up to 75% of people. There are several treatments available for those who are affected by spasticity, but this Phase III study showed efficacy in people who had not responded, or only partially responded, to current remedies.
Although Sativex can help with symptoms associated with MS, it does not alter the course of the condition.
In February, GW Pharmaceuticals released results of a smaller withdrawal study showing that Sativex is safe and effective in people who had been on it for several years. More details of that study can be found here.
Sativex can currently be prescribed to people with MS by a GP on a named patient basis. This means that if a particular GP sees a need for Sativex he or she can prescribe it a patient but it is not widely available to people affected by MS. If GW Pharmaceuticals are successful in their application to the Medicines and Healthcare Regulatory Authority (MHRA), Sativex could be marketed in the UK as early as 2010.
This would represent the first hurdle in allowing Sativex to be widely available to people with MS. Sativex would still be subject to recommendation by the National Institutes of Health and Clinical Excellence (NICE).
Source: