Smokin Moose
Fallen Cannabis Warrior & Ex Moderator
Developed by GW Pharmaceuticals, Sativex is a whole plant medicinal cannabis extract indicated for relief of symptoms of multiple sclerosis (MS) and for treatment of severe neuropathic-related cancer pain.
Bayer has secured exclusive rights to market Sativex in the UK with the option to extend this to other countries in Europe and countries such as Canada, where Sativex received regulatory approval in 2005 for treatment of neuropathic pain associated with MS.
In August 2007, Canadian regulators approved Sativex as adjunctive analgesic treatment in adult patients with advanced cancer pain. Sativex and a related tetrahydrocannabinol (THC) medicine have been investigated in phase III trials for the relief of cancer pain, an indication for which Bayer also has the option to market the drugs.
"In Europe alone there are some 500,000 MS patients on top of the 4 million experiencing neuropathic pain."GW Pharmaceuticals has also entered into a long-term research and development alliance on medicinal cannabinoids with Otsuka Pharmaceutical, which gives Otsuka exclusive rights to develop and market Sativex in the US. The companies will jointly oversee clinical development and regulatory activities in the US.
Having secured FDA approval to conduct trials of Sativex in patients with advanced cancer, whose pain is unrelieved by opioids, the companies are on schedule to conduct the first US efficacy trial of Sativex in neuropathic-related cancer pain in 2007.
CANNABIS-BASED MEDICINES
Estimates suggest that between 10% and 30% of MS patients in Europe smoke cannabis to ease the pain and disabling symptoms of the disease. This activity is illegal and patients run the risk of prosecution. In the UK, cannabis-based medicines were in fact outlawed in 1968 after legislation banned doctors from prescribing tincture of cannabis. This preparation contained high concentrations of the active THC psychotropic ingredient and was popular among recreational cannabis users.
The UK Government gave GW Pharmaceuticals special permission to investigate medicines derived from cannabis and has indicated that the law will be changed to allow doctors to prescribe them if approved by the MHRA. This would represent a major step forward for MS patients as for the first time they would have access to safe and effective cannabis-derived drugs on prescription.
Sativex is a cannabis extract containing tetranabinex (THC) and nabidiolex (cannabidiol — CBD) as its principal component. It does not contain the active substance found in recreational cannabis and so patients taking Sativex will not become intoxicated. Sativex is administered by means of a spray into the mouth rather than smoked.
To meet demands for this innovative drug, GW Pharmaceuticals has increased production of cannabis at its fortified greenhouses to 60t/y.
CLINICAL TRIALS ON SATIVEX POINT TO GOOD EFFICACY AND SAFETY
Phase III placebo-controlled trials in about 350 patients with MS have shown that administration of Sativex as a sublingual spray is a safe and effective treatment for symptom relief. Compared with placebo, significantly more patients in the Sativex treatment arm experienced reduced neuropathic pain, spasticity, and sleep disturbances.
Further phase III data on 189 MS patients supports the earlier registration trial data. Again, treatment with Sativex produced a statistically significant improvement over placebo in spasticity, the primary endpoint, (p <0.05). Other secondary endpoints, such as the Ashworth scale, also favoured Sativex over placebo. Overall, these data have shown that Sativex produces treatment effects over and above those achieved with existing medications, which patients were allowed to continue while taking part in the Sativex trial.
Additional trials are also under way to assess the effectiveness of Sativex in treating neuropathic pain and spinal cord injury. Results from three phase III trials in patients with neuropathic pain showed that the addition of Sativex to standard therapy produced improvements over and above those obtained with existing medication. Patients in these trials had all failed to response to standard therapy and constituted a population with high clinical need.
TREATMENT OF SEVERE NEUROPATHIC PAIN
Neuropathic pain, which is frequently chronic, arises when neurones in the brain or peripheral nervous system become hyper-sensitised and generate abnormal or prolonged impulses. There are many causes of neuropathic pain including diabetic neuropathy, post-herpetic neuralgia, fibromyalgia, multiple sclerosis and cancer. Around 40% of cancer patients suffer some degree of neuropathic pain.
"Companies are on schedule to conduct the first US efficacy trial of Sativex in neuropathic-related cancer pain in 2007."Severe neuropathic pain has proved difficult to treat and evidence suggests that none of the available drugs, mainly opioids, is effective in more than 50% of patients. Thus, it represents an area of significant unmet clinical need. The encouraging data from the Sativex phase III registration trials in multiple sclerosis patients suggest cannabis-derived medicines may have a valuable place in this sector of the pain market.
MARKETING COMMENTARY
In Europe alone there are some 500,000 MS patients on top of the 4 million experiencing neuropathic pain. This fact, together with a market poorly served by currently available drugs, presents an excellent opportunity for Sativex if the encouraging results seen in multiple sclerosis are reproduced in other patient groups.
Now that Sativex has been approved for clinical use in Canada, there are hopes that other countries will eventually follow the example set by the Canadian regulators.
Bayer has secured exclusive rights to market Sativex in the UK with the option to extend this to other countries in Europe and countries such as Canada, where Sativex received regulatory approval in 2005 for treatment of neuropathic pain associated with MS.
In August 2007, Canadian regulators approved Sativex as adjunctive analgesic treatment in adult patients with advanced cancer pain. Sativex and a related tetrahydrocannabinol (THC) medicine have been investigated in phase III trials for the relief of cancer pain, an indication for which Bayer also has the option to market the drugs.
"In Europe alone there are some 500,000 MS patients on top of the 4 million experiencing neuropathic pain."GW Pharmaceuticals has also entered into a long-term research and development alliance on medicinal cannabinoids with Otsuka Pharmaceutical, which gives Otsuka exclusive rights to develop and market Sativex in the US. The companies will jointly oversee clinical development and regulatory activities in the US.
Having secured FDA approval to conduct trials of Sativex in patients with advanced cancer, whose pain is unrelieved by opioids, the companies are on schedule to conduct the first US efficacy trial of Sativex in neuropathic-related cancer pain in 2007.
CANNABIS-BASED MEDICINES
Estimates suggest that between 10% and 30% of MS patients in Europe smoke cannabis to ease the pain and disabling symptoms of the disease. This activity is illegal and patients run the risk of prosecution. In the UK, cannabis-based medicines were in fact outlawed in 1968 after legislation banned doctors from prescribing tincture of cannabis. This preparation contained high concentrations of the active THC psychotropic ingredient and was popular among recreational cannabis users.
The UK Government gave GW Pharmaceuticals special permission to investigate medicines derived from cannabis and has indicated that the law will be changed to allow doctors to prescribe them if approved by the MHRA. This would represent a major step forward for MS patients as for the first time they would have access to safe and effective cannabis-derived drugs on prescription.
Sativex is a cannabis extract containing tetranabinex (THC) and nabidiolex (cannabidiol — CBD) as its principal component. It does not contain the active substance found in recreational cannabis and so patients taking Sativex will not become intoxicated. Sativex is administered by means of a spray into the mouth rather than smoked.
To meet demands for this innovative drug, GW Pharmaceuticals has increased production of cannabis at its fortified greenhouses to 60t/y.
CLINICAL TRIALS ON SATIVEX POINT TO GOOD EFFICACY AND SAFETY
Phase III placebo-controlled trials in about 350 patients with MS have shown that administration of Sativex as a sublingual spray is a safe and effective treatment for symptom relief. Compared with placebo, significantly more patients in the Sativex treatment arm experienced reduced neuropathic pain, spasticity, and sleep disturbances.
Further phase III data on 189 MS patients supports the earlier registration trial data. Again, treatment with Sativex produced a statistically significant improvement over placebo in spasticity, the primary endpoint, (p <0.05). Other secondary endpoints, such as the Ashworth scale, also favoured Sativex over placebo. Overall, these data have shown that Sativex produces treatment effects over and above those achieved with existing medications, which patients were allowed to continue while taking part in the Sativex trial.
Additional trials are also under way to assess the effectiveness of Sativex in treating neuropathic pain and spinal cord injury. Results from three phase III trials in patients with neuropathic pain showed that the addition of Sativex to standard therapy produced improvements over and above those obtained with existing medication. Patients in these trials had all failed to response to standard therapy and constituted a population with high clinical need.
TREATMENT OF SEVERE NEUROPATHIC PAIN
Neuropathic pain, which is frequently chronic, arises when neurones in the brain or peripheral nervous system become hyper-sensitised and generate abnormal or prolonged impulses. There are many causes of neuropathic pain including diabetic neuropathy, post-herpetic neuralgia, fibromyalgia, multiple sclerosis and cancer. Around 40% of cancer patients suffer some degree of neuropathic pain.
"Companies are on schedule to conduct the first US efficacy trial of Sativex in neuropathic-related cancer pain in 2007."Severe neuropathic pain has proved difficult to treat and evidence suggests that none of the available drugs, mainly opioids, is effective in more than 50% of patients. Thus, it represents an area of significant unmet clinical need. The encouraging data from the Sativex phase III registration trials in multiple sclerosis patients suggest cannabis-derived medicines may have a valuable place in this sector of the pain market.
MARKETING COMMENTARY
In Europe alone there are some 500,000 MS patients on top of the 4 million experiencing neuropathic pain. This fact, together with a market poorly served by currently available drugs, presents an excellent opportunity for Sativex if the encouraging results seen in multiple sclerosis are reproduced in other patient groups.
Now that Sativex has been approved for clinical use in Canada, there are hopes that other countries will eventually follow the example set by the Canadian regulators.
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