Sativex
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Sativex is an oromucosal (mouth) spray developed by the UK company GW Pharmaceuticals for multiple sclerosis patients, who can use it to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms. Sativex is also being prescribed to alleviate pain due to cancer and has been researched in various models of peripheral and central neuropathic pain. Sativex is distinct from all other pharmaceutically produced cannabinoids currently available because it is derived from botanical material, rather than a solely synthetic process. Sativex is a pharmaceutical product standardised in composition, formulation, and dose. Its principal active cannabinoid components are the cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). The product is formulated as an oromucosal spray which is administered by spraying into the mouth. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD.
Approved by Health Canada under a licence with conditions (NOC/c) for prescription use[1] in April 2005, Sativex is the world's first pharmaceutical prescription medicine derived from the cannabis plant. The product is approved in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis,[1] and more recently for pain due to cancer.[1][2].
Sativex is available in a number of countries as an unlicensed medicine, which enables doctors to prescribe the product to individual patients who they consider may benefit. Most unlicensed prescriptions are currently written in the UK but the product has been exported from the UK to a total of 21 countries to date. It is also available in Catalonia, Spain, for 600 patients suffering from multiple sclerosis and a number of other conditions under a compassionate access programme (130 of the patients will be people with multiple sclerosis, a further 130 will be patients with neuropathic pain arising from a range of medical conditions, 40 will be suffering from anorexia and malnutrition caused by AIDS, and the remaining 300 will be cancer patients undergoing chemotherapy and suffering from nausea and vomiting).
In February 2007, GW and Otsuka Pharmaceutical announced an exclusive agreement for Otsuka to develop and market Sativex in the United States. Sativex has received permission from the US regulatory authority, the FDA, to enter directly into late stage Phase III trials in the US. The first large scale US trial, Spray Trial, for cancer patients is underway and due to complete at the end of 2009. The 336-patient, double-blind, randomised, placebo-controlled study is evaluating the effect of Sativex in relieving average daily pain, reducing the use of breakthrough opioid medications, improving the quality of sleep and relevant aspects of quality of life among other outcome measures.
In December 2005, GW and the Spanish pharmaceutical company Almirall announced an exclusive agreement for Almirall to market Sativex in Europe (excluding the UK). In the UK and Canada, Bayer HealthCare have been appointed as exclusive distributors.
In clinical trials, Sativex has generally been well tolerated. [3][4][5]
Compare dronabinol (marketed as Marinol), a synthetic version of THC (that does not contain cannabidiol).
[edit] References
- ^ a b c "GW Pharmaceutical". www.gwpharm.com. http://www.gwpharm.com/. Retrieved on 2008-08-08.
- ^ "Sativex - Investigational Cannabis-Based Treatment for Pain and Multiple Sclerosis Drug Development Technology". www.drugdevelopment-technology.com. http://www.drugdevelopment-technology.com/projects/sativex/. Retrieved on 2008-08-08.
- ^ Wade D, Makela P, Robson P, House H, Bateman C (2004). "Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients". Mult Scler 10 (4): 434–41. doi:. PMID 15327042.
- ^ Wade D, Makela P, House H, Bateman C, Robson P (2006). "Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis". Mult Scler 12 (5): 639–45. doi:. PMID 17086911.
- ^ Wade D, Robson P, House H, Makela P, Aram J (2003). "A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms". Clin Rehabil 17 (1): 21–9. doi:. PMID 12617376.
[edit] External links
- http://www.gwpharm.com/ GW Pharmaceuticals Website
- http://www.spraytrial.com/ Sativex Cancer Pain Study
