Sativex™ (Tincture of Cannabis) 

By Dr. David Bearman, Contributing Writer for The Cannabis Times

Dr. Geoffry Guy, MD and successful phytochemical pharmaceutical entrepreneur, decided to launch G.W. Pharmaceuticals in 1998 after attending a meeting of Multiple Sclerosis (MS) patients in London where he heard stories of pain relief and decreased spasticity from smoking marijuana.1  His company very quickly received approval from the British Home Office to grow cannabis under highly controlled conditions and to develop extracts for use in clinical trials.2  

In 1999 GW’s tincture of cannabis started being clinically tested in England for its effectiveness in treating muscle spasm and pain related to multiple sclerosis and neuropathic pain. (*Note:  A tincture is made by immersing the flowering tops of the cannabis in alcohol, leaving them in the mixture for several weeks and then straining off the plant material.  The cannabinoids are soluble in alcohol, so after the plant material is strained off we’re left with alcohol infused with cannabinoids, tincture of cannabis.3

This effort arose from a 1997 House of Lords Science and Technology Committee a report on cannabis and its medicinal attributes.4 (1997 Report on Cannabis, of Science and Technology Committee of the British House of Lords)  The government was motivated to act because of concern over the relatively large number of British citizens suffering from MS being arrested for use of marijuana.

GW’s cannabis plants are grown under secure computer-controlled conditions in six greenhouses located in a secret place in the south of England.  Locals have identified an old munitions plant as the GW grow site.  GW has propagated a variety of different strains of cannabis.  Each of the 6 greenhouses is home to a different strain of cannabis.  Each greenhouse contains 10,000 marijuana plants and in each of the greenhouses all 10,000 plants are a clone of the others in that building.5

They are producing plants with significant quantities of THC, CBD (cannabidiol), THC-V (the propyl analogue of THC), CBC-V (the analogue of cannabichromene) and CBG (cannabigerol). GW has produced a tincture of cannabis product (trade name Sativex®) composed of a 50/50 combination of two different strains of cannabis. One of the strains is high in THC for its therapeutic and the other high in CBD because CBD’s decrease THC-induced euphoria.6

THC is the most pharmacologically active chemical in cannabis and a euphoriant.  The other 50% of the tincture is from another strain of cannabis that contains a high amount of cannabinoidiol (CBD), a largely pharmacologically inert ingredient in cannabis, which is an anti-euphoriant.

Sativex offers an improvement over Marinol, the synthetic delta 9 THC, which the U.S. government guided through the FDA approval process in 1985.  The only pharmacologically active component of Marinol is delta 9 THC.  Sativex is a liquid, whole plant alcohol extract applied via a sublingual mouth spray.  It contains all the alcohol soluble cannabinoids, phenoids and flavinoids in the cannabis plant, not just THC.

Studies have found this whole plant medicinal cannabis extract developed by GW Pharmaceuticals, to be effective for relief of the symptoms of pain, muscle spasm and depression associated with multiple sclerosis (MS), and for the treatment of severe neuropathic pain.61  As early as Monday, 10 September 2001, Reuters News source reported that this cannabis spray helps 77% of pain patients. With these studies in hand, GW later sold Bayer A.G. the exclusive rights to market Sativex in the UK and Canada.

In April 2005, Health Canada approved Sativex for sale in Canada and in June 2005, Bayer began marketing Sativex there.  In November of 2005 the British Home Office approved British physicians to write prescriptions for patients returning from Canada who had used the medicine there.

Finally, in December 2005, the U.S. FDA approved a Phase III clinical trial for Sativex here in the U.S. of A.  These studies are to determine if tincture of cannabis is effective in relieving intractable pain in cancer patients.  It got formally underway in November 2007.  The most recent issue of the International Association of Cannabis Medicine reported that both Great Britain and Spain are on the verge of approving Sativex for sale as a pharmaceutical in their country.

(Note:  By way of full disclosure the author owns stock in GW Pharmaceuticals(less than .001 of 1 %.) 

1 Medical Marijuana Report of the Science and Technology Committee of the House of Lords.

2 GW Pharmaceuticals website www.gwpharm .com.

3 Fred Gardner, Anderson Valley Advertiser 4/20/05, Canada Approves Sativex for MS.

4 op. cit. House of Lords Science & Technology Report

5 op. cit GW Pharmaceuticals website.

6 David Bearman, MD – Emerging, Issues for the 21st century, ABC-Clio online book.

Dr. David Bearman, MD Contributing Writer for The Cannabis Times

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