sativex( liquid pot) will be fda approved soon

Discussion in 'Fibromyalgia Main Forum' started by charlenef, Apr 22, 2007.

  1. charlenef

    charlenef New Member







    Today, a leading neurology journal - European Journal of Neurology (EJN) reports a study1 which shows that Sativex, a cannabis based medicine, significantly reduces intractable spasms and stiffness (spasticity) in people with Multiple Sclerosis (MS).

    Spasticity is one of the most common symptoms of MS, occurring in up to 84% of patients1. Spasticity can severely impact quality of life and is one of the most difficult symptoms of MS to treat1.

    The study, a randomised, double-blind trial, led by Professor Christine Collin from the Royal Berkshire and Battle NHS Trust, Reading, UK, saw Sativex or placebo added to existing anti-spasticity medication. Sativex demonstrated significant superiority to placebo in reducing spasticity (p<0.05). Further, the addition of Sativex produced a more than 30% improvement in spasticity in 40% of the people treated1.

    Fern Andrews, a person with MS who has participated in clinical trials with Sativex, commented: "Spasticity can make the simple daily activities that most people take for granted, seem daunting. Just dressing and moving around the home can be difficult and I often have to rely on a carer for support. With Sativex, I'm able to choose how much I take depending on how bad my symptoms are - which is a real benefit".

    Christine Jones, Chief Executive of the MS Trust said, "Effective relief of spasticity is extremely important to people with MS. Spasticity and muscle spasms are not only distressing and painful, they can have a negative impact on quality of life. The results of this study add to the growing body of evidence that cannabis-based medicines can be effective in helping to relieve this common symptom of MS."

    About the study published in the European Journal of Neurology:

    The six week study was conducted in 189 MS patients, all of whom were experiencing significant levels of spasticity and had failed to gain adequate relief from currently available anti-spasticity medications. Patients enrolled in the study continued to take their existing medication throughout the trial1.

    Sativex®:

    Sativex (THC:CBD), an endocannabinoid system modulator, is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids D9-tetrahydrocannabinol (THC) and cannabidiol (CBD).

    Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient This formulation allows for flexible dosing, ideal for the variable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated in the study.

    Sativex has been developed by UK-based GW Pharmaceuticals plc. It is approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is currently being reviewed by European regulatory authorities for the symptomatic relief of spasticity in MS and, on approval, will be exclusively marketed by Bayer HealthCare in the UK.

    Spasticity:

    Spasticity results from more than one group of muscles contracting incorrectly, causing spasms or stiffness. Spasms are uncontrollable muscle contractions and can be painful. They can be a particular problem at night causing disruption of sleep. Limbs may shoot away or bend upwards towards the body and severe spasms may make the back arch off the bed or chair.

    Stiffness of the limbs is common and can make it difficult to perform normal activities, particularly delicate movements of the hand and fingers. If the leg muscles are affected it can make walking difficult. Pain can be associated with spasticity. Current treatments are often only partially helpful.

    About Bayer HealthCare:

    Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division, Bayer Schering Pharma AG, comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases. http://www.bayerhealthcare.com

    About GW Pharmaceuticals plc:

    GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. GW's shares are publicly traded on AiM, a market on the London Stock Exchange.

    GW's clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems. http://www.gwpharm.com

    References:

    1. Collin C et al. Randomised controlled trial of cannabis based medicine in spasticity caused by Multiple Sclerosis. European Journal of Neurology, March 07

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  2. Poppy2

    Poppy2 New Member

    I may have to ask my Doc. about that, next time I see him. I have those symptoms, and they are pretty bad. Ya never know! Thanks Poppy
  3. charlenef

    charlenef New Member

    ME/CFS/CFIDS Watch
    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.


    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.
    posted by Ingrid at Friday, July 21, 2006

    1 Comments:
    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
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