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IACM-Bulletin of 04 March 2007

Science: Sativex effective against spasticity in MS patients in clinical trial

Results of a clinical study on the cannabis extract Sativex in patients with multiple sclerosis, which have already presented on the website of GW Pharmaceuticals and in the IACM-Bulletin earlier, have now been published in the EURopean Journal of Neurology. Satives contains equal amounts of THC and CBD. The study forms part of the application for aproval of Sativex for MS spasticity submitted in September 2006 in four EURopean countries.

A total of 189 subjects with MS and spasticity received either Sativex (124 patients) or a placebo (65 patients) for six weeks. All subjects continued to use their current medication. Participants who were treated with the cannabis extract perceived a significantly stronger reduction in spasticity compared to the control group. An objective measure of spasticity, the so-called Ashworth Score, was not significantly improved, but was in favour of the active treatment compared to placebo. In the cannabis group 40 per cent of patients achieved a more than 30 per cent improvement. Eight withdrawals from the study were attributed to side effects. Six were on active preparation and two on placebo. Researchers concluded that the cannabis extract "may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS."

The abstract is available online at:
www.cannabis-med.org/studies/study.php
More information on the study is available on the website of GW Pharmaceuticals
(www.gwpharm.com).

(Source: Collin C, Davies P, Mutiboko IK, Ratcliffe S, for the Sativex Spasticity in MS Study Group. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. EUR J Neurology 2007;14(3):290–296.)

USA: Advocates of the medical use of cannabis sue the federal government

Based on the study results on smoked cannabis in HIV associated nerve pain Americans for Safe Access sued the federal government on 21 February over its claim that cannabis has no accepted medical benefits. The study conducted at the University of California in San Francisco, which was published in February 2007 had demonstrated that the use of cannabis is beneficial in this condition. The lawsuit accuses the U.S. Department of Health and Human Services of engaging in "arbitrary and unlawful behavior" that prevents "sick and dying persons from seeking to obtain medicine that could provide them needed, and often lifesaving relief."

The California-based advocacy group wants a judge to force the department and the Food and Drug Administration to stop giving out information that casts doubt on the efficacy of cannabis in treating various illnesses. "The FDA position on medical cannabis is incorrect, dishonest and a flagrant violation of laws requiring the government to base policy on sound science," a spokesman of Americans for Safe Access said in a statement.

(Source: Associated Press of 21 February 2007)

News in brief

Science: Parkinson's disease
According to research by scientists of Stanford University (USA) with animal models of Parkinson's disease the combined administration of a dopamine-2 receptor agonist and a substance, which increases endocannabinoid concentrations, effectively reduce motor deficits of the disease. Researchers conclude that their findings "suggest approaches for the development of therapeutic drugs for the treatment" of Parkinson's and similar diseases. (Source: Kreitzer AC, Malenka RC. Nature 2007;445(7128):643-7.)

Economy: GW and Otsuka
GW Pharmaceuticals announced on 14 February that the company has entered into a long term strategic alliance with Otsuka Pharmaceutical. The relationship has commenced with the signing of an exclusive license and development agreement to develop and market Sativex® in the United States. (Source: Press release of GW Pharmaceuticals of 14 February 2007, www.gwpharm.com)

Science: Neuroprotection
In animal studies it was shown that tolerance developed to the neuroprotective effects of THC against brain damage, but no tolerance developed to the neuroprotective effects of cannabidiol (CBD). (Source: Hayakawa K, et al. Neuropharmacology. 2007 Feb 20; [Electronic publication ahead of print])

Science: Anxiety and depression
In an Australian study the use of cannabis before the age of 15 was associated with a higher risk to experience anxiety and depression in early adulthood. Researchers had followed 3239 subjects from birth to the age of 21. (Source: Hayatbakhsh MR, et al. J Am Acad Child Adolesc Psychiatry 2007;46(3):408-417.)

Science: Smell
In animal research scientists of the University of Gottingen, Germany, found out that cells that are responsible for the perception of odours in the nose are influenced by cannabinoids. Blocking of CB1 receptors by cannabinoid receptor antagonists reduced the sensitivity to odours, while the treatment with cannabinoids increased sensitivity. Lead researcher Dr. Dirk Czesnik said in a newspaper article that this makes sense. In case of hunger endocannabinoid levels are increased in the brain and hungry people do perceive odours more strongly. "The more cannabis acts, the stronger is the sensitivity to odours." (Source: Die Welt of 26 February 2007; Czesnik D, et al. Proc Natl Acad Sci U S A. 2007 Feb 14; [Electronic publication ahead of print])

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