Sativex from GW Pharmaceuticals is the first fully approved cannabis medicine. It is an oral spray containing THC and CBD, used in the treatment of patients with multiple sclerosis (MS). Today, Sativex is available in at least 25 countries, including Canada and many EU countries.
What is Sativex and who can use it?
Sativex is primarily marketed as an add-on treatment for spastic muscle paralysis associated with Multiple sclerosis. In addition to the ability to reduce severe spastic symptoms, Sativex has also been shown to effectively treat neuropathic symptoms And one overactive bladder in patients with MS.
This product has been approved as a medicine for MS. Clinical trials up to phase III have been conducted in the United States to prove whether it is also possible to use it as a supplement to treat tumor pain, especially for people who do not respond to high doses of opiates.
For now, the answer is no, because GW CEO Justin Gover explains“Although we missed the primary endpoint of this trial, the positive data from the Phase II program allows us to believe that Sativex can effectively relieve tumor-related pain in the patient population.”
Although marketed under the trade name Sativex, this drug is commonly known as nabiximols. It is an extract made from two (absolutely secret) cannabis strains using ethanol and CO2.
Sativex is an oral spray (acting on the mucous membranes of the mouth) to be applied under the tongue. The product is essentially a cannabis oil tincture and contains THC and CBD in almost equal proportion: each spray contains a fixed dose of 2.7 mg of THC and 2.5 mg of CBD.
Worldwide availability and distribution of Sativex
In June 2010, Sativex was officially approved for the first time. Its launch in Canada came shortly after its market launch in the UK. It was the start of an unprecedented success story. Sativex is currently sold in at least 25 countries, including the Netherlands, Switzerland, Germany, France, Spain, Italy, Austria, Poland, Australia and New Zealand .
Sativex also appears to be close to approval in the United States. After some delay caused by the COVID-19 pandemic, GW has resumed its Phase III clinical trial. In a press release, Justin Gover hoped that Sativex will be approved as an official drug in the US market by the end of 2021.
GW Pharmaceuticals is not the only player in the distribution of Sativex. In the UK, Sativex is distributed and marketed by pharmaceutical giant Bayer, while Almirall has distribution rights across Europe. The annual report of this Spanish group shows Sativex sales above 30 million euros in 2019, about 20% more than in 2018.
What might seem like a gold mine to outsiders, actually falls short of expectations. In 2010, Piper Jaffray, one of America’s leading investment banks, forecast sales of nearly $150 million (EU and Canada).
Natural cannabis flowers (or cannabis herb, or buds), increasingly prescribed in Europe, are a thorn in the side of investors. In addition, Sativex is struggling with a price problem: in 2019, a the monthly ration costs more than 500 € UK. In Australia, the price for a six to eight week supply was over €400.
History of Sativex – retrospective
Cannabis is an old medicine and has been used as a remedy for thousands of years. However, it wasn’t until the 1990s that scientists gradually began to understand how cannabis works in the body. The discovery of the endocannabinoid system was an important breakthrough and laid the foundation for future scientific progress.
GW Pharmaceuticals was the first company to seriously tackle cannabis drug development. GW was founded in 1998 by Geoffrey Guy, a scientist who believed in cannabinoid potential.
Justin Gover came on board only a year later. As always, the first years were difficult. It took more than 10 years before Sativex hit the market. However, each figure must be put into perspective: almost no drug reaches the market without delays or setbacks.
Today, GW produces 20 tons of cannabis per year, from which THC and CBD are extracted. The exact location where the cannabis is grown is top secret. The production facility is guarded 24 hours a day and each plant is genetically fingerprinted to allow tracking, in case of theft.
Is Sativex less effective than herbal cannabis?
Sativex, made by GW Pharmaceuticals, has been hailed by some as a wonder drug, while others have dismissed it as mere quackery. The harshest critics have even gone so far as to claim that it is part of a larger conspiracy to legitimize undercover medical cannabis. That way, they say, pharmaceutical companies could profit from Sativex while ensuring that much cannabis research remains illegal.
But what about the effectiveness of Sativex? What are the scientists saying? Several studies have shown that Sativex effectively treats the symptoms of spastic muscle paralysis associated with MS and neuropathies (nerve pain) caused by MS and cancer. Proponents of Sativex argue that the added value of this medicine lies in the fact that, unlike herbal cannabis, it can be used for standardized treatments with fixed dosages.
However, Sativex obviously has no unique or special properties other than the fact that it can be professionally processed, packaged and sold in uniform doses. Indeed, Sativex is a simple cannabis tincture based on CO2 and ethanol and still contains all the terpenes and the cannabinoids that can be found in any other cannabis extract. It may have specific medicinal effects associated with the strains used, but there is no rock solid evidence for this.
Additionally, many criticize it for being slower and less effective than traditional methods of consuming cannabis. It is clear from patient surveys published online that people prefer to consume herbal cannabis over Sativex. Normally these patients find Sativex to be less effective in relieving pain, although other surveys suggest that it may be very effective in reducing muscle spasms.
Arguments in favor of Sativex
Let’s not forget that Sativex and GW Pharmaceuticals have clearly proven to be powerful tools in the fight for global recognition of medicinal cannabis. Unfortunately, healthcare systems in most Western countries today operate in a way that requires a realistic approach to making a new drug available to the general public. It means using methods that grassroots activists generally don’t like.
In these systems, cannabis must be fragmented and turned into a fixed-dose medicine for it to be considered up to the standards of modern medicine. GW Pharmaceuticals has now provided such a product, taken the necessary steps and carefully followed the rules of the game every step of the way. In doing so, they have managed to make a cannabis-based medicine available in over 25 countries around the world, even in those lagging behind in the legalization of medical cannabis.
From an ethical standpoint, it is entirely reasonable to criticize the hypocrisy with which this company has in the past pushed for legal reforms that might benefit it but have been substantially of little help to the home growers who were considered as competitors harming its business. However, companies like GW are also viewed positively for their strong lobbying for reforms in countries that would otherwise resist them.
Whatever the final judgment on the future developments of GW Pharmaceuticals (with Sativex), we have to wait and see what the ultimate effect of this company’s actions will be on the cannabis industry as a whole. The coming years will be decisive for the cannabis legalization movement and, in this process, Sativex will surely play an important role.
Do you use Sativex in the treatment of MS? Or do you know someone who uses Sativex? We are very interested in hearing about your experience, especially if you are an herbal cannabis consumer. Tell us about it in the comments below, or write to us on Facebook. We look forward to hearing your feedback!
This article is not a substitute for professional medical advice, diagnosis or treatment. Always consult your physician or other licensed healthcare professional. Do not delay in seeking medical advice or disregard medical advice because of anything you have read on this website.
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