Look what I found!

[Guest guest]

Looked

it up, and here’s an article I came across! I would

consider it if I could tolerate any side effects. I’m super sensitive to

most meds. Even the pain meds I already take. L there are people here in

Oregon who have Medical Marijuana cards, but there’s no way I can smoke

anything anymore!

Smiles,

Jackie

SATIVEX - INVESTIGATIONAL CANNABIS-BASED

TREATMENT FOR PAIN AND MULTIPLE SCLEROSIS

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 pain. Bayer has secured

exclusive rights to market Sativex in the UK with

the option to extend this to other countries in Europe and Commonwealth

countries such as Canada.

In March 2003, GW Pharmaceuticals submitted

a product licence application for Sativex to the UK Medicines and Healthcare Products

Regulatory Agency (MHRA) and hoped to secure

approval by the end of that year. However, queries from the regulators have

seen approval repeatedly delayed and raised the question of whether Sativex will ever be approved in the UK. GW Pharmaceuticals and Bayer will not seek wider European

approval until UK regulators have given the green light. Meanwhile, Sativex has won preliminary approval to be prescribed as

a medicine in Canada, where it is indicated for the treatment of neuropathic pain associated with MS. GW

Pharmaceuticals is also to seek FDA approval to begin clinical trials in the

US.

Prospects for Sativex were boosted

following the release of long-term data suggesting that chronic use of cannabinoids is more effective in relieving symptoms of

multiple sclerosis than short-term use. The data, from the Cannabinoids in Multiple Sclerosis Research (CAMS),

compared cannabinoid treatment over 15 and 52 weeks

in MS patients.

Sativex and a related tetrahydrocannabinol (THC) medicine are also undergoing

phase III trials for the relief of cancer pain. If this indication is

approved, Bayer has an option to market these drugs for neuropathic-related

cancer pain.

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, released in June 2004, 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, this new data has 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.

Recent data from an independent study (CAMS) were presented at the

British Association Science Festival. They showed that when administered over

52 weeks to MS patients, treatment with cannabinoids

proved more effective in alleviating muscle stiffness than during a shorter,

15-week period. In the initial 15-week trial, the results of which were

published in 2003, patients reported relief in muscle stiffness, rigidity and

mobility, but these findings could not be independently confirmed by physiotherapists.

Of the 667 patients who participated in the short-term phase of CAMS, more

than 500 continued to receive treatment for up to 52 weeks. Patients were

given either whole cannabis extract, capsules containing a synthetic version

of THC, or placebo. While the CAMS trial did not involve the use of Sativex, the encouraging results nonetheless help to

reinforce the medical case for Sativex in MS.

Additional trials are also under way to assess the effectiveness of Sativex in treating cancer pain and spinal cord injury.

Anecdotal evidence suggests that Sativex and

related compounds can dull severe pain while allowing patients to perform

daily activities.

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.

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. Regulatory approval of Sativex will

set an important precedent for the use of cannabis-derived drugs.

To meet demands

for Sativex, GW

Pharmaceuticals has increased production of cannabis at its fortified

greenhouses to 60t/y. (Source: ABPI)

Overview of new

classes of pain relieving drugs in development.

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. (Source: ABPI)

[Guest guest]

Thank you, Jackie! I used to live in Oregon--amazingly advanced;

people even vote using hard copy and receipts and the votes are

counted by a careful system! They are the only state to get author

ization to give Medicaid benefits to the working poor, and the only

state to allow a physician to give a dying patient a lethal dose--re

gardless of what one thinks of that last one--that is a very COOL.

if WET state! Love to you, n

Look what I found!

Looked it up, and here’s an article I came across! I would consider it if I could tolerate any side effects. I’m super sensitive to most meds. Even the pain meds I already take. L there are people here in Oregon who have Medical Marijuana cards, but there’s no way I can smoke anything anymore!

Smiles, Jackie

SATIVEX - INVESTIGATIONAL CANNABIS-BASED TREATMENT FOR PAIN AND MULTIPLE SCLEROSIS

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 pain. Bayer has secured exclusive rights to market Sativex in the UK with the option to extend this to other countries in Europe and Commonwealth countries such as Canada.

In March 2003, GW Pharmaceuticals submitted a product licence application for Sativex to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and hoped to secure approval by the end of that year. However, queries from the regulators have seen approval repeatedly delayed and raised the question of whether Sativex will ever be approved in the UK. GW Pharmaceuticals and Bayer will not seek wider European approval until UK regulators have given the green light. Meanwhile, Sativex has won preliminary approval to be prescribed as a medicine in Canada, where it is indicated for the treatment of neuropathic pain associated with MS. GW Pharmaceuticals is also to seek FDA approval to begin clinical trials in the US.

Prospects for Sativex were boosted following the release of long-term data suggesting that chronic use of cannabinoids is more effective in relieving symptoms of multiple sclerosis than short-term use. The data, from the Cannabinoids in Multiple Sclerosis Research (CAMS), compared cannabinoid treatment over 15 and 52 weeks in MS patients.

Sativex and a related tetrahydrocannabinol (THC) medicine are also undergoing phase III trials for the relief of cancer pain. If this indication is approved, Bayer has an option to market these drugs for neuropathic-related cancer pain.

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, released in June 2004, 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, this new data has 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.

Recent data from an independent study (CAMS) were presented at the British Association Science Festival. They showed that when administered over 52 weeks to MS patients, treatment with cannabinoids proved more effective in alleviating muscle stiffness than during a shorter, 15-week period. In the initial 15-week trial, the results of which were published in 2003, patients reported relief in muscle stiffness, rigidity and mobility, but these findings could not be independently confirmed by physiotherapists. Of the 667 patients who participated in the short-term phase of CAMS, more than 500 continued to receive treatment for up to 52 weeks. Patients were given either whole cannabis extract, capsules containing a synthetic version of THC, or placebo. While the CAMS trial did not involve the use of Sativex, the encouraging results nonetheless help to reinforce the medical case for Sativex in MS.

Additional trials are also under way to assess the effectiveness of Sativex in treating cancer pain and spinal cord injury. Anecdotal evidence suggests that Sativex and related compounds can dull severe pain while allowing patients to perform daily activities.

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.

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. Regulatory approval of Sativex will set an important precedent for the use of cannabis-derived drugs.

To meet demands for Sativex, GW Pharmaceuticals has increased production of cannabis at its fortified greenhouses to 60t/y. (Source: ABPI)

Overview of new classes of pain relieving drugs in development.

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. (Source: ABPI)

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