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Everything you need to know about Sativex

Sativex is a cannabinoid drug made by GW Pharmaceuticals, which contains equal amounts of CBD and THC. It is sometimes prescribed to multiple sclerosis patients to help treat and manage their symptoms. Sativex is prescribed in more than 20 countries around the world, although it is still waiting approval in the United States. However, the success of this drug worldwide makes it a trailblazer in the world of cannabis – it’s even prescribed in the United Kingdom, where even medical marijuana remains illegal.

For serious conditions such as multiple sclerosis and intractable epilepsy, there are often few working treatments, and even fewer that don’t come with harsh side effects. But the cannabis-based Sativex is offering a lifeline to patients in need. However, if it’s the cannabinoids which are having the beneficial effect, why not just prescribe medical cannabis itself to patients instead of a pharmaceutical drug? Let’s learn more about Sativex.

Sativex – a ground-breaking treatment for multiple sclerosis

It’s slightly ironic that a UK-based company is leading the movement for cannabinoid medicine in the pharmaceutical industry, given Britain’s regressive position on marijuana. Sativex, or nabiximol, is used by multiple sclerosis patients primarily to treat spasticity – CBD and THC are noted for their antispasmodic properties. A mouth spray, cannabinoids in Sativex are taken into the bloodstream via sublingual absorption, making it a fast-acting drug. As cannabinoids, CBD and THC are treasured compounds, since it’s believed that this group of chemicals is unique to the cannabis family.

Using Sativex

Sativex is unique from many cannabinoid drugs in that it is made with a natural cannabis extract rather than synthetic cannabinoids. And Sativex even contains tetrahydrocannabinol (THC), with all its psychoactive effects. The even mix of CBD and THC promotes the “entourage effect,” a theorised synergistic reaction between cannabinoids.

Many medical cannabis products only contain non-psychoactive CBD, and it’s true that this cannabinoid alone is phenomenally effective for many ailments, and even rare child epilepsy. But for multiple sclerosis patients, the combination of CBD and THC makes for more potent antispasmodic and analgesic properties than when they are isolated. CBD and THC are also thought to have neuroprotective effects, with the US Department of Health and Human Services holding a patent on their use as neuroprotectants.

A list of other useful cannabinoids and terpenes are present in the cannabis extracted used to make Sativex. The terpenes have therapeutic qualities and are responsible for the aroma of cannabis, while the more obscure cannabinoids exhibit subtle medicinal properties.

Sativex is an oralmucosal spray, with its ingredients absorbed by soft tissues in the cheeks and the underside of the tongue. These areas are loaded with cannabinoid receptors, which are activated by phytocannabinoids (CBD, THC etc.).

Sativex appears to be a better-quality cannabinoid treatment than nabilone and dronabinol, two synthetic cannabinoid drugs which are sometimes prescribed to reduce cancer pain and treat loss of appetites and AIDS-related nausea. These synthetics, however, are only imitations of THC and not comparable to the cannabinoid in its natural form.

What is Sativex used for?

Many government-funded clinical trials on humans researching the medicinal potential of cannabis have involved Sativex. World-class testing – which means conducting randomized, double-blind placebo-controlled trials –  has consistently demonstrated how the antispasmodic properties of CBD and THC are beneficial for multiple sclerosis patients, leading to the drug’s approval in several countries. Sativex is also sometimes used to treat ganglia necrosis, an unusual muscular condition.

Sativex is prescribed in Canada to manage cancer pain, although the United States has carried out clinical trials in this area and have not found that cancer and chemotherapy pain can be sufficiently remedied with the drug. Despite initial trials producing positive results, Sativex was shown to be less effective in later experiments.

The one-to-one combo of CBD and THC in the drug is enough to produce moderate psychoactive effects in people not used to cannabis. However, studies documenting patients’ use of Sativex over one year found no evidence of a tolerance build-up from regular use.

According to GW Pharmaceuticals, there is scope for Sativex to be introduced as a medication for several other ailments in the future, such as cerebral palsy, schizophrenia and epilepsy. Interest in cannabinoid science is soaring, so expect many more clinical trials using Sativex and other GW drugs in the next few years.

Sativex vs cannabis

While Sativex is indeed a natural cannabis extract with natural cannabinoids and terpenes, it’s still somewhat different from the cannabis tinctures you can buy at your dispensary.

Sativex is specifically designed to be an efficacious multiple sclerosis treatment, so it perhaps isn’t quite as effective for other conditions. In addition to checking whether Sativex does reduce MS symptoms, clinical trials are also used to determine the safety and effectiveness of the drug.

Furthermore, you can guarantee that Sativex will always provide a precise and consistent drug, as it’s a standardized pharmaceutical. The product is designed to emit an equal amount of cannabinoids with every spray, an accuracy beyond what typical cannabis tinctures can achieve.

When medicating with cannabis flower or crude extracts, there will be slight variations in the concentration of phytocannabinoids, terpenes and phytochemicals from plant to plant. Some patients are not prepared for the possible inconsistencies with flower or crude extracts and are more comfortable with a standardized drug like Sativex.

Although, for advocates of whole-plant medicine, actual cannabis is a better form of treatment than Sativex, as it’s certain to contain all of the 400-plus chemicals – and therefore all of the more than 110 cannabinoids – found in the herb. Research into cannabinoid medicine is still in its early phases, and scientists are still piecing together how the most prominent cannabinoids work with each other to produce the effects they do.

Given that Sativex is an expensive drug, many patients take their chances with either cannabis flower or high-grade cannabis oils, with varying ratios of CBD to THC. These full-extract products can draw out the “entourage effect” even more so than Sativex. Not that we’re recommending throwing out your meds and switching to cannabis without your doctor – it’s ultimately an individual decision – but more and more people are going down that route.

We’re now going to focus in on the benefits and disadvantages of medicating with Sativex (nabiximols) over marijuana.

Advantages: in many countries, nabiximols are the only legal form of medical cannabis and you have the assurance that these treatments are high-quality and deliver a standardized dose. For multiple sclerosis patients, Sativex is made specifically for you, and has been tested extensively to ensure its safety.

Disadvantages: only a few people are eligible to receive nabiximols on prescription, and if you are fortunate enough to have access, they are expensive. Moreover, nabiximols do not contain the complete cocktail of cannabinoids that you get with natural extracts.

The Sativex experience

It is true that Sativex, while being an approved, prescription medication in many countries, does gives users a high. Although the cannabinoid profile of Sativex is nowhere near high enough in THC to produce an intense psychoactive trip. Studies into Sativex have shown that the mild psychoactivity does not have any adverse effects on cognitive function. And since users can decide exactly how much they want their dose to be, you have much more control when using Sativex than smoking bud.

However, nabiximols are known to produce some unpleasant side effects, such as dizziness, diarrhea, fatigue, drowsiness, dry mouth, headaches and nausea. Most users tolerate Sativex well, though, and do not find the side effects as severe as from some conventional medicines.

How much will Sativex set me back?

If the government refuses to subsidise your Sativex treatment, then it’s going to be very expensive. A good example is New Zealand, where just 26 people who were approved to use the drug actually went and got a prescription. Sativex costs, on average, $1,200 New Zealand dollars per month, which works out to an annual prescriptioncost of almost $20,000 US dollars.

The United Kingdom is also experiencing pricing and accessibility issues with Sativex. A London School of Medicine gave a damning verdict of the drug, saying there was no proof it was “cost-effective.” However, should the drug go legal in the United States courtesy of FDA approval, it’s expected to be much cheaper for patients, with costs covered either by private insurance or government subsidies.

In what countries is Sativex legal?

More than 20 countries have legalized Sativex, however in all of those, it is only available on prescription. The United States may still be waiting, but these countries have legalized nabiximols for prescription use:

  • Austria
  • Canada
  • France
  • Germany
  • New Zealand
  • Spain
  • United Kingdom

The Middle East and Latin America are cited areas of interest for GW Pharmaceuticals, as they bid to get Sativex legalized across the globe as a treatment for MS. The stumbling block for FDA approval here in the US is the federal government’s prohibitionist position on cannabis, with the drug classed as Schedule I, with no accepted medicinal use. This also applies to the two crucial components in Sativex, CBD and THC.

GW Pharmaceuticals aren’t just pushing Sativex, but a CBD-rich drug called Epidiolex, which is designed to treat several types of rare, medication-resistant epilepsy conditions. Epidiolex is pure CBD, containing no psychoactive THC. The drug has successfully completed phase 3 clinical trials in the United States as a treatment for conditions such as Lennox-Gastaut syndrome and Dravet syndrome.

But there’s no need to wait for Epidiolex. Hemp-derived CBD products are here already, and legal to all US residents. These products are made with a hemp extract that contains less than 0.3 percent THC.

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