GW Pharmaceuticals Announces Results of MS Spasticity Study Confirming Sativex Has No Long-Term Negative Effect on Cognition

“-Provides Further Evidence of Long-term Efficacy-

GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces top-line results from a 12 month placebo-controlled study of Sativex in patients with spasticity due to Multiple Sclerosis (MS).

The study results confirm the reassuring safety profile of Sativex and provide further evidence of long-term efficacy.”

More: http://finance.yahoo.com/news/gw-pharmaceuticals-announces-results-ms-060000735.html

Marijuana mouth spray for cancer patients tough to abuse – NBC

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“The medical marijuana drug Sativex, which could be approved in the United States in the coming years as a treatment for pain relief, has little potential for abuse, experts say.

The British pharmaceutical company GW Pharmaceuticals is currently testing the drug, which is delivered as a mouth spray and called Sativex, in clinical trials. The company plans to seek U.S. Food and Drug Administration approval for the drug as a treatment for cancer pain when the trials are completed, likely sometime in 2014, a spokesperson for GW Pharmaceuticals told MyHealthNewsDaily.

The active ingredients in Sativex, known as cannabinoids, are derived from the cannabis plant. It is the first marijuana-based drug to be made by extracting the compounds from the plant, rather than synthesizing them. Two other drugs, Marinol and Cesamet, based on synthetic cannabinoids, were approved by the FDA in the 1980s.”

More: http://vitals.nbcnews.com/_news/2012/01/31/10280678-marijuana-mouth-spray-for-cancer-patients-tough-to-abuse?lite

Cost effectiveness of oromucosal cannabis-based medicine (sativex®) for spasticity in multiple sclerosis.

“Spasticity is common in patients with multiple sclerosis (MS) and is a major contributor to disability. Sativex®, an oromucosal spray containing cannabis-based medicinal products, has been found to be effective in reducing spasticity symptoms.

Our objective was to estimate the cost effectiveness of Sativex® plus oral anti-spasticity medicines compared with the current standard treatment for moderate or severe spasticity in MS in the UK.

CONCLUSIONS:

Using a willingness-to-pay threshold of £30 000 per QALY, Sativex® appears unlikely to be considered cost effective by UK funders of healthcare for spasticity in MS. This is unfortunate, since it appears that Sativex® use is likely to benefit some patients in the management of this common consequence of MS.”

http://www.ncbi.nlm.nih.gov/pubmed/23072659

Endocannabinoid system modulator use in everyday clinical practice in the UK and Spain.

“Spasticity is a disabling complication of multiple sclerosis. Some commonly used oral medications include baclofen, tizanidine, anticonvulsants and benzodiazepines, but their benefits are modest.

Sativex(®) (GW Pharmaceuticals PLC, Porton Down, UK; Laboratorios Almirall, SA, Barcelona, Spain) is a unique cannabinoid-based medicine with two main active ingredients; 9-δ-tetrahydrocannabinol, which acts mainly on cannabinoid 1 receptors in the CNS and plays a key role in the modulation of spasticity and spasms, and cannabidiol, which has different properties, including minimization of the psychoactivity associated with 9-δ-tetrahydrocannabinol. Sativex is indicated for symptomatic improvement in adult patients with moderate-to-severe multiple sclerosis-related spasticity who have not responded adequately to other first- or second-line antispasticity medications, and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy.

Over the past couple of years, Sativex has been approved for use in a number of European countries and ongoing postmarketing studies are evaluating the possible risks associated with Sativex treatment by systematically collecting all suspected adverse reactions that occur in patients from the start of treatment. Interim data from the UK as well as Spanish Sativex safety registries confirm that clinical benefit is maintained over the longer term despite the expected trend for deterioration owing to disease progression.

 Even after more than 2 years of use, no new safety/tolerability signals have emerged with Sativex, including no evidence of driving impairment and no relevant incidence of falls or other adverse events of concern, such as psychiatric or nervous system events.

Sativex appears to be a well-tolerated and useful add-on therapy in patients who have not achieved an adequate response with traditional antispastic agents.”

http://www.ncbi.nlm.nih.gov/pubmed/23369054

The Cannabinoid CB2 Receptor as a Target for Inflammation-Dependent Neurodegeneration

“THE CANNABINOID CB2 RECEPTOR AS A BIORATIONAL TARGET FOR THE TREATMENT OF NEURODEGENERATION. The presence of CB2 receptors in microglia in the human Alzheimer’s diseased brain suggests that CB2 may provide a novel target for a range of neuropathologies.

 The first approved cannabinoid drugs were analogues of Δ9-tetrahydrocannabinol (Δ9-THC). Dronabinol is a natural isomer of THC that is found in the cannabis plant, and Marinol contains synthetic dronabinol. Marinol, and another analogue nabilone (Cesamet ) are used to prevent nausea and vomiting after treatment with anti-cancer medicines. More recently, GW-100 (Sativex) which combines nearly equal amounts of Δ9-THC and cannabidiol in a whole plant extract from cultivated cannabis, has been approved in Canada…

We conclude that the administration of CB2 agonists and antagonists may differentially alter microglia-dependent neuroinflammation. CB2 specific compounds have considerable therapeutic appeal over CB1 compounds, as the exclusive expression of CB2 on immune cells within the brain provides a highly specialised target, without the psychoactivity that plagues CB1 directed therapies.

In addition, CB2 activation appears to prevent or decrease microglial activation.

In a rodent model of Alzheimer’s disease microglial activation was completely prevented by administration of a selective CB2 agonist.”

http://www.ncbi.nlm.nih.gov/pubmed/18615177