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Sativex

sativexSativex is Schedule I in the United States.

Addictive Potential: Low

Emergency Room Visits Yearly: Unknown

Mandatory Minimum Sentence: Unknown

Mechanism of Action: Cannabinoid receptor agonist

Overview:

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 standardized 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.

In June 2010 the Medicines and Healthcare products Regulatory Agency of the United Kingdom licensed Sativex as a prescription only medicine for the treatment of spasticity due to Multiple Sclerosis. This regulatory authorization represents the world’s first full regulatory approval for the medicine. Sativex is being marketed in the UK by Bayer Schering Pharma.

Sativex is expected to be approved and launched in Spain for MS spasticity in the second half of 2010. In Spain and other European markets (excluding the UK), Sativex will be marketed by Almirall.

In Canada, Sativex has been approved by Health Canada under a licence with conditions (NOC/c) for prescription use. The product is approved in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis, and also for pain due to cancer.

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 28 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 trials in the US. The first large scale US Phase IIb trial, Spray Trial, for cancer patients reported results in March 2010. GW and Otsuka are now planning to commence Phase III development of Sativex in cancer pain in the second half of 2010.

Side Effects and Adverse Reactions:

The most common side effects of Sativex are dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued. These side effects are common to many other prescription medications, particularly pain medications (GWPharma, 2009).

Research:

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