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. The product is approved in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis. In June 2007, Health Canada issuing a Qualifying Notice for the approval of Sativex in the relief of cancer pain, with the final approval of this indication expected by fall 2007. It is available in the UK as an unlicensed medicine which enables UK doctors to prescribe the product to individual patients who they consider may benefit. 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. Otsuka is a major global pharmaceutical company, best known for its antipsychotic blockbuster medication, Abilify. 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 in the US for cancer patients is expected to start in summer 2007. The 300-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 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.
Compare dronabinol (marketed as Marinol), a synthetic version of THC.
- 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. 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. 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. PMID 12617376.
- http://www.gwpharm.com/ GW Pharmaceuticals Website