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IACM-Bulletin of October 19, 2014

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Science UK — New cannabis extract may be helpful in ulcerative colitis according to clinical study

Data of a clinical phase 2 study with a new cannabis extract of the British company GW Pharmaceuticals show promising signals of efficacy in patients with ulcerative colitis. The pilot trial was a 10-week double-blind, placebo controlled study of GWP42003 extract, which contains cannabidiol (CBD) as the primary cannabinoid, but also tetrahyrdocannabinol (THC) and other cannabinoids. The trial included 60 adult patients with ulcerative colitis who continued to have symptoms from the condition despite treatment with salicylates, and in some cases immunosuppressive therapy. GWP42003 was given as a twice daily oral capsule up to a maximum dose of 250mg twice daily.

During the early weeks of the study, more patients withdrew from the active treatment group than from the placebo treatment group so that the analysed group comprised only 17 patients on GWP42003 and 27 on placebo. Most of these withdrawals were due to minor THC-related adverse events such as dizziness. At the end of the study the physician assessed 82% of the patients in the GWP42003 group as having normal or mild disease, compared with 52% in the placebo group. 93% of the patients regarded their condition as “improved,” compared with 60% of the placebo group.

Press release by GW Pharmaceuticals of 14 October 2014

Science USA — CBD extract Epidiolex effective in epilepsy according to physician reports

On 14 October the British company GW Pharmaceuticals announced new encouraging physician reports of efficacy and safety associated with the Epidiolex studies, which have been presented at a company’s event in New York City. Physician reports of efficacy and safety data have been made available on 58 children and young adults with treatment-resistant epilepsy, who have been treated for a period of at least 12 weeks.

12 patients with Dravet syndrome reported a median overall reduction in seizure frequency of 51%-72%. 12 patients with atonic seizures reported a median overall reduction in seizure frequency of 52%-76% Atonic seizures are a type of seizures that consist of a brief lapse in muscle tone, which may be indicative of Lennox-Gastaut syndrome. Data on 58 patients with a wide range of drug-resistant epilepsies treated with Epidiolex showed a median overall reduction in total seizure frequency of 36%-51%.

Press release by GW Pharmaceuticals of 14 October 2014

News in brief

Israel — Clinical study on CBD in cancer to start in November

Researchers at the Hassadah Medical Center in Jerusalem have announced their intent to conduct a Phase II clinical trial to assess the impact of CBD (cannabidiol), a non-psychoactive cannabinoid of the cannabis plant, as single treatment among cancer patients. Only patients who have exhausted conventional anti-cancer treatments will be eligible to participate in the study. Once enrolled in the trial, participants will receive CBD for a period of eight weeks.

Alternet of 10 October 2014

Clinicaltrials.gov

Canada — 500,000 patients expected to get access to cannabis in the coming years

“It is expected that some 500,000 users, and dozens of commercial producers will soon be approved” under a new Canadian program for the medical use of cannabis, a group of researchers estimated in an article for the International Journal of Drug Policy.

Centre for Applied Research in Mental Health and Addiction, Faculty of Health Sciences, Simon Fraser University, Vancouver, Canada.

Fischer B, et al. Int J Drug Policy. 2014 Sep 22. [in press]

UK — Cost agency says Sativex not cost-effective for the threatment of multiple sclerosis

The cannabis extract Sativex developed by the British firm GW Pharmaceuticals for treating spasticity in multiple sclerosis has been rejected as not cost-effective in the company's home market. The National Institute for Health and Care Excellence (NICE), which determines if medicines are worth using on England's state health service, said the modest benefits and high cost of Sativex did not justify its use.

Reuters of 8 October 2014

Morocco — Opposition party wants to legalize cannabis for medical uses

A law suggested by the opposition Party of Authenticity and Modernity that was founded by a close associate of the king wants to legalize production of cannabis. The entire crop would go to a state agency that would use it to produce new cannabis-based medications, and eventually for industrial uses as well.

News24 of 7 October 2014

The Netherlands — Court does not punish cannabis growers

A Dutch court has refused to punish two cannabis growers, criticising a government policy that criminalises the drug's production while allowing its sale in coffee shops. “The court finds the suspects guilty,” the court in Groningen said in its judgment, but “no punishment will be applied.” Judges found that the cultivation was done in the spirit of the law on soft drugs, namely “in the interests of public health and so as not to disturb public order.” The Groningen growers were always open with the police about their activities, always declared their cannabis income to the government and paid tax on it.

Sky News of 17 October 2014

Canada — Centre for Addiction calls for legalization of cannabis

The Centre for Addiction and Mental Health (CAMH) has released a new evidence-informed report on the issue of cannabis control in Canada. It recommends a legalization with strict regulation approach to cannabis control.

CAMH of 9 October 2014

UK — Most people think that the war on drugs has failed

An increasing proportion of Britons favours a more liberal approach to drugs, according to a survey commissioned by the journal Observer. An overwhelming majority of 84% also believes that the so-called "war on drugs" is futile. More than half (52%) support the introduction of initiatives like that recently pioneered by two US states, Colorado and Washington.

The Guardian of 5 October 2014

USA — Report says that CBD cannabis products often of low quality

According to a report by the non-profit advocacy group Project CBD analytical testing of various CBD products revealed significant quantities of industrial solvents, which could pose health risks to consumers. Potency testing also identified products with considerably lower levels of CBD and higher levels of THC than advertised.

Report “Hemp Oil Hustlers” by Project CBD of 14 October 2014

USA — Zynerba Pharmaceuticals to develop transdermal cannabinoid therapies

The US company Zynerba Pharmaceuticals announced the successful closing of 13 million dollars (about 10.2 million euros) in funding to develop transdermal cannabinoid therapies. Zynerba prepares to initiate Phase 1 clinical studies in 2015 on a THC transdermal patch and on a cannabidiol (CBD) transdermal gel.

Press release by Zynerba Pharmaceuticals of 15 October 2014

Science/Animal — Inhibitor of 2-AG degradation effective against neuropathic pain

JZL184, an inhibitor of 2-AG degradation, was tested in a mouse model of neuropathic pain. Researchers concluded from their analyses that the endocannabinoid anandamide most likely mediates the pain reducing effect of JZL184 in this model.

Department of Diagnostic and Biological Sciences, University of Minnesota, USA.

Iryna AK, et al. Pharmacol Res. 2014 Oct 7. [in press]