Sativex vs Medical Cannabis: What's The Difference?
Brian Asked
What is sativex and how is it different than medical cannabis?
Summary
Answer
What is Sativex?
Sativex is the brand name for nabiximols, a prescription medication that is approved in many countries outside of the US for the treatment of spasticity associated with Multiple Sclerosis. The active ingredients in Sativex (nabiximols) are THC and CBD, at about a 1:1 ratio, and the medication is available as an alcohol-based spray.
Multiple Sclerosis (MS)
MS is a disease of the central nervous system (brain and spinal cord) where the immune system attacks the protective sheath, called myelin, that covers nerve fibers. This causes communication problems between the brain and the body. Eventually, MS can cause deterioration of nerve fibers and permanent damage. People with MS may lose the ability to walk or ambulate. Spasticity is a common symptom of MS that includes muscle stiffness, spasms, and neuropathic pain.
Sativex for the Treatment of MS
Sativex was developed to help treat spasticity associated with MS. Sativex is intended to help patients who don't respond to other therapies and who demonstrate improvement during an initial trial of the medication.
In clinical trials, Sativex reduced the severity of spasticity for patients with MS. This was measured by having patients fill out a rating scale about their symptoms.
How is Sativex Different than Medical Cannabis?
Sativex is different from medical cannabis in a number of ways, including its formulation and design, regulatory classification, and the evidence supporting its use.
Formulation and Design
Sativex is formulated as a buccal spray (a spray that is directed to the inside of the cheeks in your mouth). Each spray of Sativex delivers 100 microliters which contains 2.7 mg of THC and 2.5 mg of CBD. Sativex uses two different cannabis extracts, one containing THC (Tetranabinex®) and one containing CBD (Nabidiolex®) to make an approximately 1:1 ratio mix of the two cannabinoids. Sativex also contains the following inactive ingredients: alcohol, peppermint oil, and propylene glycol.
Regulatory Classification
Sativex is available by prescription only in the following countries:
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Czech Republic
- Denmark
- Finland
- France
- Germany
- Iceland
- Ireland
- Israel
- Italy
- Luxembourg
- Netherlands
- New Zealand
- Norway
- Poland
- Portugal
- Slovak Republic
- Sweden
- Switzerland
- United Kingdom
Why isn't Sativex approved in the US? It failed to show a difference from placebo in a phase III study.
Despite no US approval, Sativex has undergone significant laboratory and clinical testing to help regulators understand more about its safety and effectiveness. Medical cannabis products come in a plethora of different dosage forms and are usually only laboratory tested for contaminants and labeled dosage accuracy. The testing that pharmaceuticals are subject to is significantly more involved and burdensome due to high regulatory standards set by health regulatory agencies.
How is Sativex Used?
Patients self-titrate Sativex. This means they adjust how much of the drug they use based on how their symptoms respond to each dose. A maximum of 12 sprays per day (equivalent to a dose of about 32 mg of THC and 30 mg of CBD) were used in clinical trials. The average dose in clinical trials was 4 - 8 sprays per day which is around 10-20 mg of THC and CBD.
Most patients tolerated the medication well, but not everyone will respond to Sativex or some people might have side effects that make the drug intolerable.
Side Effects of Sativex
Unexpectedly, the side effects of Sativex are similar to that of medical cannabis. After all, they contain two of the same active ingredients. But remember, Sativex is delivered as a buccal spray, so some of these side effects may be related to the route of administration.
Very common side effects
- Fatigue
- Dizziness
- Stinging or discomfort in the mouth
Common side effects
- Disorientation
- Problems concentrating
- Depression
- Changes in appetite
- Change in taste
- Dry mouth
- Loss of balance
- blurred vision
- Nausea
- Constipation or Diarrhea
- Lack of Energy
Conclusion
To summarize, Sativex is different from medical cannabis in a number of ways, including its formulation and design, and the evidence supporting its use. However, the main difference is that Sativex can only be obtained outside the US by prescription. While medical cannabis is not completely interchangeable with Sativex, the clinical evidence available about the drug can help inform best practices when using medical cannabis to treat symptoms of MS. If you want to learn more about medical cannabis for MS please check out our dedicated article on this topic! Thanks again for your question and feel free to reach back out anytime.
- Sativex(®) (tetrahydrocannabinol + cannabidiol), an endocannabinoid system modulator: basic features and main clinical data Sativex(®) (tetrahydrocannabinol + cannabidiol), an endocannabinoid system modulator: basic features and main clinical data.
- Sativex: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain Sativex: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain.
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