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 and spasticity. 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 license with conditions (NOC/c) for prescription use in April 2005, Sativex is the world's first pharmaceutical prescription medicine derived from the cannabis plant. It is available in the UK as an unlicensed medicine imported from Canada to satisfy its prescription to individual patients. 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 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 early 2006, Sativex received permission from the US regulatory authority, the FDA, to enter directly into late stage Phase III trials in the US. In late 2006, GW Pharmaceuticals will begin its first Phase III trial in the US for cancer patients. The 250-patient, double-blind, randomized, placebo-controlled study will evaluate 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 clinical trials, Sativex has generally been well tolerated.

Compare dronabinol (marketed as Marinol), a synthetic version of THC.

[edit] External links

• http://www.gwpharm.com/ GW Pharmaceuticals Website