Friday, July 21, 2006

Sativex can significantly reduce nerve pain in MS patients, a study has shown

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. Full story. Excerpt:
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.
sativex2.jpg

Picture shows Sativex.

Further reading:

GW Pharmaceuticals Press Release 15th November 2005 - UK Named Patient Prescribing for Sativex
http://www.gwpharm.com/sativex.asp

Home Office Sativex Details

Following the GW Pharmaceuticals Press Release of 15th November 2005, several THC4MS clients have contacted the Home Office to enquire how they can obtain Sativex.

Your GP will need to apply to the Home Office to prescribe Sativex to you. Your GP will need to provide the following:

a) your personal details - full name, address, age, gender
b) a brief indication of the clinical need
c) the dosage total amount required (the manufacturer, GW Pharmaceuticals can help with this information - telephone 01980 557026 or email enquiries@gwpharm.com).

Your GP can forward this information to:
Mike Evans
Home Office, Drugs Branch,
6th Floor, Peel Building,
2 Marsham Street,
London.
SW1P 4DF

Updated 22/12/2005

The MS Society at its website has produced the following information in response to queries from people affected by MS about Sativex

What is Sativex?
Sativex is an oral spray containing a cannabis extract produced by GW Pharmaceuticals. You take it by spraying it under your tongue or to the inside of your cheeks. You can control the dose of Sativex you take by varying the number of sprays.

What symptoms will Sativex help with?
Sativex has been made available for relief of symptoms associated with MS. It has not been specified for any particular symptom. Information from GW Pharmaceuticals says clinical trials conducted in people with MS have shown promising results in the relief of spasticity, nerve pain, sleep disturbance, and bladder symptoms.

How can I get a prescription for Sativex?
As of 15 November 2005, GPs in the UK could prescribe Sativex on a 'named patient' basis for people with MS. 'Named patient' means that the prescribing GP takes the decision to prescribe it based on your individual circumstances.

Why is this drug coming from Canada?
At the moment, Sativex does not have a UK licence and is not available through normal NHS channels. However, your doctor has the right to prescribe an unlicensed medicine, under his/her own responsibility, if he or she feels that it is in the best interests of the patient.

When your doctor has agreed with the patient that Sativex is appropriate, then they simply need to write a prescription. Sativex can be supplied to a pharmacist in order to fill the prescription. The only additional information required by the pharmacist in the case of Sativex, is confirmation that Sativex is being supplied for the treatment of MS.

If your doctor requires any more information about this procedure, it can be obtained from GW Pharmaceuticals, at the number given at the bottom of the this page.

I have MS. Does this mean I am automatically entitled to get Sativex from my GP?
Your GP will take into account your particular circumstances and other factors and will make a decision based on your own case. There may be reasons that Sativex does not suit you. In clinical trials, Sativex has been used in people who have not gained adequate relief from their existing treatment. While a large proportion of people with MS are helped further during treatment with Sativex, some people may not improve at all.

Why might my GP refuse to prescribe Sativex?
Sativex is not suitable for everyone. It is also not recommended for some groups of people. For example, pregnant women, the under 18 year old age group, and those with a history of a psychotic disorder would not be eligible.

Can I get a second opinion if my GP refuses to prescribe it?
As with any treatment decision, you are entitled to a second opinion.

What are the side effects? How will it react to the other drugs I take?
GW Pharmaceuticals has prepared detailed advice to GPs on warnings and precautions related to the use of Sativex. You should discuss this with your GP.

Can I drive while taking Sativex?
You are warned not to drive or do anything that needs unimpaired judgement and coordination after taking Sativex.

Will I need to pay for Sativex?
The cost of Sativex is estimated to be around £4-£5 a day for a typical user. However, because Sativex is used according to each person's response, some people will use more, and some use less than the typical amount. Whether you have to pay for this will depend on local NHS arrangements and your GP or pharmacist can advise you further. This is in addition to standard prescription charges.

For further information
MS Helpline: 0808 800 8000

Cannabis reduces symptoms of MS - Lancet report

The claims by medical users that cannabis reduces the symptoms of MS has been confirmed by UK government trials. The study, of more than 600 patients, published in the Lancet medical journal, also provided some evidence that they boosted mobility. MS sufferers have been claiming these beneficial effects for years. This study shows that cannabis really does make these ill people feel better, these claims cannot be ignored any longer. - BBC News report
- - -

GW Pharmaceuticals:
Email enquiries@gwpharm.com
Telephone 01980 557026)

Note: I would be grateful for any feedback from readers suffering from ME/CFS/PVFS and/or Fibromyalgia re Sativex. Please leave comment or email me direct. Thanks for all other comments and emails received, much appreciated. Sorry, can't keep up with replies as well as blogging.

2 Comments:

Anonymous Anonymous said...

medical marijuanna definitely helps me. I've been ill with cfs/me since'85 and i've had severe cfs/fms since 2000.

I use sativa for energy and indica for sleep and hash for pain control. I'm allergic to all pharmaceuticals.

Fogggygyrl

September 13, 2006  
Anonymous Drug development said...

I didn't quite understand how you can produce the drug in a country that you don't have a license in.

August 17, 2008  

Post a Comment

<< Home