Sativex is a marijuana-based pharmaceutical that is now approved in over 24 countries.
Sativex is a whole cannabis extract that comes as a peppermint-flavored mouth spray. The first pharmaceutical drug of its kind, Sativex can be prescribed for patients with multiple sclerosis in countries such as Canada, Australia, the United Kingdom, and Spain.
While the drug has not been approved in the United States, that could be changing very soon. Yet many wonder how Sativex actually differs from marijuana, which remains an illegal drug.
Here are some basic facts about Sativex that you should know:
1. Sativex is a marijuana extract.
Despite its pharmaceutical sounding name, Sativex is made from the cannabis plant itself. The company behind it, GW Pharmaceuticals, has openly stated that Sativex contains all of the same compounds found in cannabis.
The difference is that Sativex is manufactured using modern processes that allow the medicine to be standardized – meaning that each bottle of the spray contains the same concentration of active ingredients. The formula for Sativex includes a 1:1 equal ratio of THC to CBD.
A lack of standardization happens to be one of the main sticking points for doctors who hesitate to support medical marijuana.
2. Sativex is made in a country where cannabis is illegal.
Sativex is developed and manufactured in the UK, where GW Pharmaceuticals is based.
Despite the fact that marijuana remains illegal in the UK, even for medical purposes, the government issued a license to GW Pharmaceuticals in 1998 allowing the company to grow cannabis for research and development.
Currently, Sativex is an approved treatment in the UK. At the same time, advocacy groups are still fighting to have medical marijuana legalized in the country.
3. Sativex has all the same side effects as marijuana.
Since Sativex is made from cannabis, it also produces a high. While the ratio of THC to CBD may be less than that of more potent cannabis strains, Health Canada’s Fact Sheet warns that Sativex can still cause “symptoms of cannabinoid intoxication.”
On the other hand, Sativex is administered as a mouth spray and has been found to cause oral discomfort in 20-25% of patients. Medical marijuana users do not typically experience this problem and often rely on vaporizers to avoid the negative effects of smoking.
4. Sativex could hit pharmacies as early as this year.
Sativex has been gradually making its way through the FDA approval process. It is currently in Phase III trials, the final phase of clinical trials, as a treatment for cancer-related pain.
In early 2014, Sativex was granted Fast Track designation by the FDA in order to accelerate the drug’s approval.
GW Pharmaceuticals says it expects to receive final FDA approval within this year or the next. Once approved, the drug could be prescribed by doctors and sold in pharmacies across the United States.
5. Sativex is expensive.
The cost of Sativex in countries where it is approved has already proven to be a barrier.
In New Zealand, an average annual prescription of Sativex costs about $16,000 (US). Likewise, according to Professor Gavin Giovannoni of The London School of Medicine, Sativex has “not been proven to be cost-effective” in the UK, which has led a large number of MS patients to continue using illegal forms of cannabis.
The main problem for most patients seems to be a lack of insurance coverage. Still, companies face significant costs associated with obtaining clinical data that will satisfy health authorities. These costs often factor into the price that patients end up paying.
6. Sativex is not considered cannabis under federal law.
While some might think that FDA approval of Sativex would make it impossible for the U.S. government to continue defending its classification of cannabis as a Schedule I drug, it may not be that difficult after all.
As it turns out, Sativex has been given its own scientific name: nabiximols. Like other marijuana-based pharmaceuticals, such as Marinol (dronabinol) and Cesamet (nabilone), this allows Sativex to be scheduled separately from cannabis.
Most countries where Sativex is sold have used this approach in order to maintain a ban on medical marijuana.
7. Sativex may be useful for more than multiple sclerosis.
While Sativex is currently approved solely for the treatment of MS-related muscle spasticity, the drug is also being trialed for a number of other conditions.
Besides the company’s cancer pain trials in the U.S., Sativex is being studied in the UK as an add-on treatment for brain cancer. Previous studies have also suggested benefits in treating arthritis and neuropathic pain.