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IACM-Bulletin of 28 March 2010

Spain/UK: Sativex is expected to get approval for the treatment of spasticity in multiple sclerosis soon

Sativex, a cannabis-based medicine for multiple sclerosis and other diseases is expected to win regulatory approval in Britain and Spain in the second quarter of 2010, its producer GW Pharmaceuticals said on 18 March. The company said regulators in both countries had concluded there were no major quality, safety or efficacy issues remaining to be resolved. Talks are now focused on points of clarification related to the patient information leaflet.

The medicine, which is sprayed under the tongue, is to be marketed in Britain by Germany's Bayer and in the rest of EURope by Spain's Almirall. GW will get a 10 million pounds (15 million US Dollars) payment from Bayer on British approval, while a further 2.5 million pounds is payable by Almirall following both regulatory and pricing approval in Spain. Clinical trials have shown Sativex reduces spasticity in multiple sclerosis patients who do not respond adequately to existing therapies. GW had originally hoped to win approval in 2003 for its drug but the medicine has been hit by a string of regulatory delays in EURope. Analysts estimate peak sales of Sativex in multiple sclerosis at about 50 to 100 million pounds a year.

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(Sources: GW Pharmaceuticals of 18 March 2010, Reuters of 18 March 2010)

Science: Promising clinical study results for the cannabis extract Sativex in the treatment of cancer pain

On 23 March GW Pharmaceuticals announced preliminary results of a Phase II trial evaluating the efficacy and safety of Sativex in the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. This trial was performed in conjunction with GW’s licensing partner for Sativex in the United States, Otsuka Pharmaceutical. The principal investigator is Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York. Preliminary results show that the study met its key objectives and provided efficacy and safety data that support advancing to Phase III clinical trials.

This randomized double-blind placebo-controlled parallel-group study recruited a total of 360 patients in 14 countries in North America, EURope, Latin America and South Africa, and evaluated three dose ranges of the cannabis extract while patients remained on stable doses of their background optimized opioid therapy during the study. The primary efficacy measure of the study was a patient assessment of pain on a scale of 0 to 10, which was analysed using three conventional methodologies. Two of the three analyses showed statistically significant results in favour of Sativex. For example, the change from baseline in average pain score showed a statistically significant difference between the Sativex low dose group and placebo. The low and mid dose Sativex groups, when combined, were also statistically significantly superior to placebo.

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(Source: GW Pharmaceuticals of 23 March 2010)

USA: Californians will decide on the legalization of cannabis in November

California will again be the flashpoint in the debate on legalization of cannabis as officials said on 24 March the question will be on the November ballot. Los Angeles County elections officials submitted their official estimate of valid signatures collected in the county on a state-wide legalization initiative, putting the number of signatures collected state-wide over the 433,971 needed to put the measure on the ballot, the Los Angeles Times reported.

The initiative would permit people age 21 or older to possess up to an ounce (28.5 grams) of cannabis for personal use. Polls indicate a majority of California voters favour legalization. Chris Lehane, a strategist for the initiative, said voters "already accept" that cannabis is commonly used. "They want to see a smart strategy," he said. John Lovell, a lobbyist for law enforcement groups, said he believes that voters will reject the proposition. "Why on Earth would you want to add yet another mind-altering substance to the legal array?" he asked.

(Source: UPI of 24 March 2010)

News in brief

USA: Arizona
The voters of Arizona will decide on the legalization of cannabis for medicinal purposes in November. A proposed initiative would allow doctor-authorized use of cannabis to relieve suffering from several specific conditions, and would allow creation of a network of non-profit shops that could sell the drug. The ballot measure also contains anti-discrimination provisions, including one that says an employer cannot fire someone who tests positive for the drug unless the company can prove the person used or possessed cannabis on the job or was "impaired" during work hours. (Source: Arizona Daily Star of 19 March 2010)

USA: Rhode Island
Altogether, 355 Rhode Island doctors have signed state forms asking the Department of Health to issue marijuana-use cards to at least one of their patients. But 21 of those doctors account for more than a third of the 1,347 medical cannabis cards issued so far. (Source: The Providence Journal of 12 March 2010)

USA: South Dakota
South Dakotans will be asked to vote on legalizing cannabis for use in treating pain, nausea and other health problems. The secretary of state's office has approved a petition seeking a state-wide vote on the proposal in November. (Source: www.chadrad.com)

Science: Depression
Animal research at the University of Mississippi, USA, shows that THC, CBD (cannabidiol) and CBC (cannabichromene) exert antidepressant-like actions. Authors note that this "may contribute to the overall mood-elevating properties of cannabis." (Source: El-Alfy AT, et al. Pharmacol Biochem Behav 2010 Mar 20 [Electronic publication ahead of print])

Science: Atherosclerosis
According to research at the University of Shanghai, China, a synthetic cannabinoid (WIN55,212-2) reduced the induction of the inflammation promoting substance TNF-alpha by oxidized low-density lipoprotein (the "bad" cholesterol). This effect was mediated by the CB2 receptor. Researchers noted that these results indicate that "the CB2 receptor may offer a novel pharmaceutical target for treating atherosclerosis." (Source: Hao MX, et al. J Lipid Res. 2010 Mar 20. [Electronic publication ahead of print])

Science: Pain
According to research with diabetic mice both CB1 and CB2 receptor agonists reduced the development of painful diabetic peripheral neuropathy. (Source: Toth CC, et al. Mol Pain 2010;6(1):16.)

Science: Cancer
According to research at the Catholic University of Korea, Seoul, a synthetic cannabinoid (WIN55,212-2) inhibited the proliferation of human cancer cells of the stomach in a dose-dependent manner and this effect was partially mediated by the CB1 receptor. (Source: Xian XS, et al. J Cell Biochem 2010 Mar 24. [Electronic publication ahead of print]).

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