At Royal Queen Seeds, we got a lot of questions about Sativex. Check out the most commonly asked questions below to find out the answers.

Questions & Answers: Sativex

👄 How much Sativex should I take per day?
Patients are advised[1] to take one spray in the evening during the first two days, and then two sprays in the evening for the following two days. Going forward, patients should increase the dose by one spray each day until they reach 12 sprays per day on day 14.
💤 What are the side effects of Sativex?
The side effects of Sativex include feeling queasy, getting sleepy, dizziness, tiredness, diarrhoea, headaches, and dry mouth.
⏳ How quickly does Sativex work?
As an oral mucosal spray, Sativex takes effect within minutes. Typically, multiple sclerosis patients begin to notice an improvement in symptoms within four weeks.
🥼 Can a GP prescribe Sativex?
No, GPs cannot prescribe Sativex throughout most of Europe. In the UK, Denmark, and other countries, only consultant neurologists and pain specialists have the authority to do so.

Although cannabis remains prohibited in much of the western world, patients can access pharmaceutical preparations under certain circumstances. Companies have developed fast-acting formulas that contain varying levels of cannabinoids to manage the symptoms of complex chronic pain conditions and disorders such as epilepsy.

As one such medication, Sativex contains multiple cannabinoids and shows promise in the treatment of complex health conditions where other treatments and modalities fail. Find out more about this cannabis product below.

What is Sativex and What’s It For?

Sativex, also known as nabiximols, harnesses a duo of cannabinoids to relieve the symptoms of several medical conditions. It comes in the form of an oral mucosal spray, with each 10ml bottle containing precisely 270mg of THC and 250mg of CBD.

The cannabis-based medicine stands as the first to be licensed in the United Kingdom. Patients also have access to Sativex under special circumstances in Spain, Germany, Switzerland, and elsewhere.

Currently, Sativex remains somewhat restricted. In most countries, only consult specialists in neurology and pain can prescribe the drug, and only specific conditions meet the criteria for a prescription.

Whether you’re looking to obtain a Sativex prescription, or simply want to learn more about cannabis-based preparation, discover everything you need to know about the medicine below.

What is Sativex and What’s It For?

Who Makes Sativex?

In case you're curious about the origins, it's worth noting the British biotechnology company GW Pharmaceuticals created Sativex. Founded in 1998, the company is one of few in the UK to hold a cultivation license that enables them to grow, possess, and supply cannabis in the name of scientific research.

The company also receives plant material from British Sugar, who own massive greenhouses devoted to growing legal cannabis in the county of Norfolk. Although the UK government currently categorises cannabis as a Class B drug, the country stands as the largest exporter of cannabis-based medicines in the world.

As well as holding the patent for Sativex, GW Pharmaceuticals also developed Epidiolex, an oral CBD solution designed to treat childhood forms of epilepsy.

The biotechnology giant Bayer secured the rights to market Sativex within the UK, and has the option to extend these rights in Europe and Canada.

How Does Sativex Work?

Sativex works by rapidly introducing cannabinoids into the bloodstream. The spray administers the solution to the oral mucosa, through which cannabinoids rapidly diffuse. Some of the solution also makes its way into the digestive tract after being swallowed, resulting in longer-lasting but amplified effects.

The active constituents of Sativex work primarily by interfacing with the endocannabinoid system, or ECS. This network of receptors exists throughout the body, including the central and peripheral nervous system. THC binds directly to a component of the ECS called the CB1 receptor, an action that appears to influence the body’s perception of painful stimuli[2].

Interestingly, CBD has a low affinity for both the CB1 and CB2 receptors. Instead, it manages to interface with the ECS by blocking enzymes that break down the endocannabinoid anandamide. Much like THC, anandamide binds to the CB1 receptor and may help to counter pain[3]. There may be other factors in play there, however, and further clinical trials are needed to confirm these ideas.

CBD also activates the TRPV1 receptor, a site that contributes to the expanded endocannabinoid system. Through this pathway, the molecule may help to manage pain and inflammation. As with the point we just brought up, though, we need further clinical studies to confirm this is exactly what's happening.

How Does Sativex Work?

What is Sativex Used For?

Throughout the UK, Europe, and Canada, specialists can prescribe Sativex for the relief of multiple sclerosis symptoms and the treatment of severe neuropathic cancer pain.

Characterised by an autoimmune response that attacks the nervous system, multiple sclerosis results in symptoms such as fatigue, vision problems, cognitive issues, and numbness and tingling. Muscles stiffness and spasms also frequently affect those with the condition. Sativex appears to relieve the spasms associated with multiple sclerosis. A clinical trial published in 2006 found the formula to be effective for spasticity and pain[5] related to the condition.

Further research published in the journal Chemistry & Biodiversity examined the effects of Sativex on pain and sleep[6]. After gathering data from Phase I-III trials involving 2000 subjects, the authors observed marked improvements in sleep quality in patients experiencing numerous pain conditions, including multiple sclerosis, peripheral neuropathic pain, and arthritis.

However, real-world data reveals that some patients don’t tolerate the psychoactive effects of Sativex well. A large study conducted in Italy collected data from 30 multiple sclerosis centres in the country[7] between January 2014 and February 2015. The researchers found that 631 out of 1597 patients stopped using Sativex due to the cognitive side effects.

Despite this, further observational data shows that Sativex also helps many patients in real-world scenarios[8]. Research published in the journal Therapeutics and Clinical Risk Management documents that 80% of patients benefited from Sativex treatment, 60% continued treatment, and only 30% discontinued Sativex due to side effects or lack of effectiveness.

Can Sativex Get You High?

So, since it contains THC, can it get you high? Well, yes. Through binding to the CB1 receptor, the THC in Sativex exerts feelings of relaxation, peace, and even euphoria in some users. However, some patients strongly dislike the sensation of getting high, and even discontinue Sativex because of the psychoactive effects.

The quantity of CBD within the formula may help to reduce the high associated with Sativex. As a non-psychoactive cannabinoid, CBD acts as a positive modulator of the endocannabinoid system[9]. This enables the molecule to reduce the negative effects of THC while enhancing the enjoyable effects.

Does Sativex have any side effects?

Studies have identified common side effects associated with the administration of Sativex. These include:

  • Dizziness
  • Drowsiness
  • Constipation or diarrhoea
  • Fatigue
  • Memory or concentration problems
  • Dry mouth
  • Change of sense of taste

There are also contraindications when it comes to prescribing Sativex. Medical professionals will not prescribe the drug to:

  • Pregnant women
  • Patients under 18 years of age
  • Patients will a history of mental health problems

Patients should also avoid driving and operating heavy machinery after taking a dose of Sativex.

Where is Sativex available?

Medical professionals in several countries have the power to prescribe Sativex. Patients in the following nations may be eligible:

  • United Kingdom
  • Spain
  • Czech Republic
  • Germany
  • Denmark
  • Sweden
  • Italy
  • Austria
  • Canada
  • Poland
  • France
  • United States

Sativex versus medical marijuana

Although Sativex stems from the cannabis plant, there are distinct differences between the effects of each. As a refined product, Sativex only utilizes a portion of the phytochemicals found within cannabis.

Pros and Cons of Sativex

As one of the first approved cannabis-based medicines, Sativex provides effective relief for many patients experiencing neuropathic pain and spasticity. However, the preparation also presents some drawbacks that make it far from perfect.

PROS
PROS
The main benefits of Sativex include:

Accurate dosage: Made by a pharmaceutical company, Sativex provides an extremely accurate dose. Each spray administers exactly 2.7mg of THC and 2.5mg of CBD.

High efficacy: Sativex produces positive changes in most patients, helping to reduce pain and other symptoms.

Major cannabinoids: The presence of THC and CBD allows Sativex to target multiple facets of the endocannabinoid system.

Easy to take: Users can take Sativex anywhere at any time thanks to the easy-to-administer spray bottle design.

CONS
CONS

Despite the positives aspects of Sativex, the formula also features some major disadvantages, such as:

Lacks other phytochemicals: THC and CBD are only two of hundreds of molecules found in cannabis, each with their own beneficial effects.

Centralised: Sativex represents the current pharmaceutical monopoly over cannabis in many countries. While prisons are full of peaceful home cultivators, giant corporations receive special licenses from governments and make millions.

Side effects: Not all patients tolerate Sativex well. Side effects such as cognitive disturbances are common.

Pros and Cons of Medical Cannabis

Medical cannabis overs some advantages over Sativex. However, the plant in its raw form also presents some issues that Sativex users don't have to worry about.

CONS
PROS
The main advantages of using the cannabis plant medicinally include:

Complex phytochemistry: Cannabis flowers harbour over 100 cannabinoids and 200 terpenes. These molecules present individual benefits and also work synergistically to enhance the overall effects of the herb.

Thousands of strains: Each cannabis cultivar features its own unique blend of molecules. Many are bred specifically to produce certain molecules that help some conditions more than others. 

Different routes of administration: Medical marijuana patients can choose from a variety of ways to take the herb. Smoking, edibles, and sublingual routes all offer different effects.
Decentralised: Where legal, growers have the option to grow their own plants and tailor their preparations in specific ways that suit them.
CONS
CONS
Although accessible, medical marijuana falls short of Sativex in a few ways:

Raw and unprocessed: Although more chemically diverse, raw cannabis flowers take a bit of work to create a formula anything like Sativex.
Less accurate dosing: Sativex offers astoundingly accurate doses. When working with medical cannabis, every bite of an edible and inhalation of smoke offers varying amounts of cannabinoids. 

Sativex and Medical Marijuana: Which is Better?

Sativex and medical marijuana offer different benefits that come to the fore in different contexts. Rather than one being better than the other, they both suit different applications. Sativex offers a proven and effective therapy specifically for cases of multiple sclerosis and neuropathic pain. On the other hand, medical marijuana offers a much more versatile, decentralised, and accessible option for a much wider variety of health conditions. At the end of the day, it's up to you and whatever your doctor decide.

External Resources:
  1. Sativex Oromucosal Spray - Summary of Product Characteristics (SmPC) - (emc) https://www.medicines.org.uk
  2. Sativex successfully treats neuropathic pain characterised by allodynia: A randomised, double-blind, placebo-controlled clinical trial - ScienceDirect https://www.sciencedirect.com
  3. Anandamide suppresses pain initiation through a peripheral endocannabinoid mechanism | Nature Neuroscience https://www.nature.com
  4. Sativex successfully treats neuropathic pain characterised by allodynia: A randomised, double-blind, placebo-controlled clinical trial - ScienceDirect https://www.sciencedirect.com
  5. Sativex®: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain https://www.tandfonline.com
  6. Cannabis, Pain, and Sleep: Lessons from Therapeutic Clinical Trials of Sativex®, a Cannabis‐Based Medicine https://onlinelibrary.wiley.com
  7. Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study) https://journals.plos.org
  8. An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray https://www.ncbi.nlm.nih.gov
  9. Effectiveness and tolerability of THC:CBD oromucosal spray as add-on measure in patients with severe chronic pain: analysis of 12-week open-label real-world data provided by the German Pain e-Registry https://www.ncbi.nlm.nih.gov
Disclaimer:
This content is for educational purposes only. The information provided is derived from research gathered from external sources.

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