Sativex product information page

Sativex is one of a handful of cannabis-based products that is available for prescription for New Zealand patients. It is used almost exclusively by people living with multiple sclerosis (MS), but in rare cases it can be prescribed for other conditions.

For many years, Sativex was the only cannabis-based product accessible in the country, though this changed in early 2017 when Peter Dunne released a list of reputable cannabis-based products that he recommended be made available in New Zealand. Today, Sativex remains one of the best options for MS patients and anyone else who experiences moderate to severe symptoms of spasticity.

Although the efficacy of Sativex has been proven in multiple clinical studies, it is not without its flaws. Its high cost has been widely criticised by both marijuana proponents and mainstream media, who argue that its hefty price tag makes it inaccessible to those who need it the most. In addition, as with just about every other medicinal product (cannabis based or otherwise) on the planet, some patients do experience negative side effects from Sativex.

With the government loosening the laws surrounding the medicinal cannabis application process, it’s likely that we’re going to see a rise in the number of people seeking Sativex prescriptions.

The purpose of this page is to provide you with all the information you may require to make an informed decision about whether Sativex is right for you. Do keep in mind that while we are firm believers in the medical potential of cannabis, we are not doctors, and we highly recommend that you consult a medical specialist before making any decision regarding your health and/or medicine choices.

What is Sativex?

Sativex is a mouth spray derived from two strains of cannabis leaf and flower. It is classified as a Schedule 2, Part 1 (Class B1) controlled drug under the Misuse of Drugs Act 1975. Made by GW Pharmaceuticals, a company that has operations in the US and the UK, Sativex is considered to be the first ever cannabis-based prescription medicine, and is now available in more than 29 countries around the world (including nations where cannabis is illegal in all other forms).

Sativex comes in a 5.5 ml spray bottle, which delivers up to 48 sprays, or a 10 ml spray bottle, which delivers up to 90 sprays. It contains the principal cannabinoids THC and CBD, which have been proven to have a range of medical applications, as well as a variety of minor cannabinoids and non-cannabinoid components.

Each 100 microlitre spray contains 2.7 mg of THC and 2.5 mg of CBD, as well as traces of inactive ingredients such as ethanol, propylene glycol and peppermint oil.

Where Sativex differs from other extracts (and why it is available in countries where other cannabis products are still illegal) is in the production process. GW Pharmaceuticals makes use of modern manufacturing techniques to carefully standardise Sativex, meaning that the cannabinoid content and concentration of the medicine is exactly the same in every spray bottle – a feat that eludes many other companies. This standardisation greatly reduces the risk for patients, allows for more accurate testing and is critical for legitimising cannabis-based products as forms of medicine.

How does Sativex work?

Satives is an oral spray. When applied, the active ingredients are absorbed into the lining of the mouth. Its ability to combat spasticity symptoms stems mostly from the THC, which acts as a partial agonist at the CB1 and CB2 cannabinoid receptors, typically found at nerve terminals. Here, the receptors influence the retrograde regulation of synaptic function, which in turn can change the effects of neurotransmitters and ultimately reduce spasticity.

Meanwhile, the CBD in Sativex is thought to play a role in calcium homeostasis while inhibiting adenosine uptake. It also serves to reduce some of the anxiety and psychoactive effects of THC.

Who is Sativex for?

In New Zealand, Sativex is prescribed to alleviate the muscle stiffness and related symptoms associated with MS. While the Sativex application process is easier than it’s ever been, patients must still meet certain criteria in order to be considered eligible.

Your doctor might prescribe you Sativex if:

  • You have MS.
  • You experience moderate to severe spasticity.
  • Your symptoms have not responded well to other anti-spasticity medicine.
  • Your symptoms show significant improvement during an initial Sativex therapy trial.

In some circumstances, Sativex can be prescribed for conditions beyond MS. This is always on a case-by-case basis, so talk to your doctor if you think Sativex could help you.

Who is Sativex not for?

It’s important to note that there are some patients who, for their own safety, health and wellbeing, should steer clear of Sativex.

You should not use Sativex if:

  • You or anyone in your immediate family has a history of mental health issues, such as psychosis, schizophrenia, etc. This does not include MS-related depression.
  • You are allergic to cannabis, cannabis extracts, or any of the ingredients found in Sativex (see ‘What is Sativex’).
  • You are breast feeding.
  • You are pregnant (unless explicitly advised by your doctor).

Does Sativex have any side effects?

The majority of patients use Sativex with few issues; indeed, studies show that many experience fewer side effects than they would with other non-cannabis-based medicines. However, side effects can and do still occur (particularly when you first begin using Sativex), and they range in severity from mild tiredness all the way to visual and auditory hallucinations.

If you experience any of the following side effects, dial back your dosage and stop using Sativex until you return to baseline. For some of the more severe side effects, you may require medical attention – talk to your doctor for more details.

According to the New Zealand Medicines and Medical Devices Safety Authority, here are some of the side effects you may experience when taking sativex:

Very common (affecting more than 10 percent of people)

  • Tiredness or dizziness

Common (affecting less than 10 percent of people)

  • Loss of balance
  • Feeling unwell, abnormal or drunk
  • Depressed or confused thoughts
  • Difficulty concentrating and remembering
  • Blurred vision
  • Changes in appetite
  • Diarrhoea or constipation
  • Mouth ulcers, burning sensation in the mouth
  • Problems with speaking
  • Dry mouth and/or altered sense of taste

Uncommon (affecting less than 1 percent of people)

  • Paranoia
  • Suicidal thoughts
  • Fluctuations in heart rate, pulse rate and/or blood pressure
  • Stomach pain
  • Swelling of the mouth
  • Fainting
  • Discolouration of the mouth and/or teeth

Keep in mind that this is not an exhaustive list, so be sure to consult your doctor if you notice any other concerning side effects.

While some of the side effects listed here may sound quite serious, remember that ALL medicines carry a similar (if not higher) level of risk. The majority of people are able to take Sativex with little discomfort.

How can I get Sativex in New Zealand?

As touched on, Sativex is only available in New Zealand with a doctor’s prescription and Ministerial approval. To obtain this prescription you may need to:

  1. Speak to your doctor, who may refer you to a specialist.
  2. Your doctor or specialist will assess you to determine if Sativex is the right option for your specific circumstances.
  3. Your doctor or specialist will apply to the Ministry of Health for prescription approval.
  4. If you are granted Ministerial approval, your doctor will prescribe you Sativex.
  5. You collect your prescription from your local pharmacy, which may need to order Sativex from a supplier.

How much Sativex should I take?

Optimal dosage can vary greatly depending on your unique biological makeup, severity of your symptoms, past experience with cannabis, and a range of other factors. When you first start using Sativex, you’ll need to do some careful experimenting to find what works best for your body.

Refer to the below table (courtesy of Medsafe) for further insight into dosage frequency for new Sativex patients:

[INSERT TABLE, BOTTOM PAGE 8: http://www.medsafe.govt.nz/Consumers/CMI/s/sativex.pdf]

When taking Sativex you should:

  • Start by using Sativex in a safe, risk-free environment until you are more familiar with the effects of the medicine.
  • Stop increasing daily sprays when you find the dosage frequency that works best.
  • Wait at least 15 minutes between sprays.
  • Use one less spray each day if you start to experience unwanted side effects.
  • Never use more than 12 sprays per day, unless your doctor advises otherwise.

How much does Sativex cost?

One of the biggest criticisms of Sativex is its incredibly high price. A monthly prescription costs more than $1,000, which puts it outside the financial means of many MS patients – particularly those who are unable work due to the severity of their symptoms.

PHARMAC is largely responsible for the high cost of Sativex. PHARMAC is a New Zealand government agency that decides which pharmaceuticals should and shouldn’t be funded. As you might have guessed, PHARMAC has decided that Sativex should not be publically funded, which means that patients must deal with the full, unsubsidised cost of the medicine.

Not only does this mean that some Kiwis are unable to afford medicine that could improve their quality of life, it also paves the way for patients – who may have heard of the medical potential of cannabis – to experiment with non-standardised, non-medicinal forms of cannabis (i.e. smoking raw leaf). Whether or not smoking cannabis in this way can improve MS symptoms is a matter of some contention; what isn’t up for debate is the fact that smoking raw leaf exposes patients to more health and legal risks than using an approved, standardised product such as Sativex.

Studies

Thanks to Sativex’s relatively long (for cannabis-based medicinal products, at least) history, there’s an abundance of clinical research demonstrating its efficacy for treating the spasticity symptoms of MS.

For example, in a 2010 investigation published in Neurological Research, researchers carried out a double-blind, randomised, placebo-controlled, parallel-group study of 337 subjects. All participants had MS spasticity that had not been fully resolved with conventional therapy methods. After 15 weeks, 79 percent of participants showed improvement on their numeric rating scale of spasticity, while as many as 98 percent of patients improved their ≥30 percent response in spasticity by at least 10 percent.

A different study, this one published in the European Journal of Neurology found similarly positive results. A randomised, double-blind, placebo-controlled, parallel-group, enriched-design study of 572 subjects resulted in more than half of the test’s participants achieving ≥20 percent improvement in spasticity in just four weeks.

The efficacy of Sativex for treating MS is perhaps best summed up by a meta analysis of three separate randomized, placebo-controlled, double-blind parallel group studies, which led researchers to the simple conclusion that “[Sativex] is well tolerated and reduces spasticity”.

It’s worth noting that while in New Zealand Sativex is largely prescribed for spasticity, a number of studies are exploring its use for treating other symptoms and conditions such as chronic pain, sleep disorders, neuropathic pain and pain caused by rheumatoid arthritis. As more of these studies come to light, it’s possible that we could see Sativex prescription eligibility criteria expand to include patients beyond those living MS and spasticity.