What Is SATIVEX & France OKs Sales of Medicine Derived From Cannabis

PARIS (AP) — The French drug safety agency has approved commercial sales of a medicine derived from cannabis for the first time in France.

France's Health Ministry said in a statement Wednesday that sales of Sativex, produced by Britain's GW Pharmaceuticals, will be allowed for the treatment of muscle spasms associated with multiple sclerosis.

Sativex contains marijuana's two best known components — delta 9-THC and cannabidiol. The company's website says the medicine has already been launched in 11 countries and approved in more than a dozen others.

A number of countries have been easing curbs on the sale of cannabis-based products for medical use in recent years, and the U.S. state of Colorado allowed the nation's first legal recreational marijuana shops to open starting this year.

What Is Sativex?

A 10ml vial of Sativex costs £125 in the UK.

TruthOnPot.com – Sativex is a patented mouth spray made from ingredients found in medical marijuana, specifically THC and CBD. Each dose of Sativex contains 2.7 mg of THC and 2.5 mg of CBD.

Oral delivery of cannabinoids has become an increasingly popular method of treatment. As it turns out, cannabinoids do not need to be inhaled, but can also be absorbed into the blood stream through the inner lining of the mouth.

While there are a number of cannabinoid-based pharmaceuticals available on the market today, Sativex is the only one that contains cannabinoids derived from the marijuana plant itself – other medications such as Marinol and Cesamet contain synthetic forms of cannabinoids.

Sativex was developed by the UK-based company GW Pharmaceuticals in 1999, who have since established international distribution partnerships with major pharmaceutical companies such as Bayer and Novartis.

Currently, Sativex is approved for the treatment of multiple sclerosis in a number of countries, including the UK, Canada, Spain, Germany, Denmark, Czech Republic, Sweden and New Zealand. Sativex is also undergoing review by other countries – such as the United States – for the treatment of multiple sclerosis as well as neuropathic and cancer-related pain.

Medical Marijuana vs. Sativex

While the cannabinoids found in Sativex come from the cannabis plant itself, there is still a major difference between Sativex and medical marijuana. Although the majority of research has focused on THC and CBD, cannabis is known to contain over 60 different cannabinoids, which are believed to provide additional benefits to patients.

As a result, the use of Sativex does not appear to result in better treatment outcomes. However, what Sativex does provide is a standardized dosing mechanism which is backed by regulatory approval and numerous clinical trials. In that sense, the greatest advantage of using Sativex may be the legal aspect of this drug.

The Controversy

The development of Sativex has been met with significant controversy, mostly because of its similarity to medical marijuana, which remains a widely prohibited form of treatment in both the UK and worldwide. Much of the controversy stems from the fact that cannabis remains a Schedule 1 drug in the UK, meaning that it has been deemed too dangerous to be used as a form of medical treatment, despite the fact that Sativex is currently considered a Schedule 4 drug.

Additionally, GW Pharmaceuticals is the only company in the UK with a license to produce medical marijuana. The company harvests an estimated 300 tons (600,000 pounds) of cannabis every year for the manufacturing of Sativex and the R&D of other marijuana-derived medications.

Although this allows GW Pharmaceuticals to conduct extensive investigations into the safety and benefits of Sativex, it also restricts patients from considering medical cannabis as an alternative. Likewise, Sativex comes at a much higher price to patients in the UK, priced at £125 for a 10ml vial.

Clinical Trials

Sativex has undergone many clinical trials spanning a variety of medical conditions, which have provided strong evidence of its therapeutic benefits.

Multiple sclerosis (MS) remains the most common use for Sativex and the results of 14 GW Pharmaceutical-sponsored studies have conclusively shown how useful it can be for the treatment of various MS-related symptoms, including spasticity, pain, bladder dysfunction and sleep problems.

The most recent study conducted on Sativex and multiple sclerosis was published in 2013 and provides a comprehensive summary of its benefits as well as the overall safety associated with long-term Sativex treatment. According to the study’s results, side-effects were mild to moderate with the most common being dizziness and fatigue. Furthermore, there seemed to be no evidence of tolerance, even though the average patient had used Sativex for close to a year prior to the study.

Sativex has also been studied in cases of pain stemming from a variety of sources, including cancer and various neuropathic conditions. Once again, these studies provide overwhelming evidence of the role of cannabinoids in reducing pain, although this is not a novel finding to anyone familiar with cannabinoid research. However, the FDA is currently awaiting the results of advanced clinical trials regarding cancer-related pain and Sativex, which GW Pharmaceuticals hopes to have completed and approved by the FDA by the end of 2013.

Interestingly, Sativex has also been investigated as a treatment for rheumatoid arthritis and bladder dysfunction (in MS patients), both of which have revealed positive results. Studies show that Sativex can reduce pain on movement, pain at rest and quality of sleep in patients with arthritis as well as reduce urinary urgency, incontinence episodes, frequency and nocturia in patients suffering from MS-related bladder problems. Unfortunately, further studies on these specific conditions have yet to be conducted since 2006.

The Future of Sativex

While GW Pharmaceuticals continues to conduct research on Sativex, the company has also been involved with developing a number of other cannabinoid-based pharmaceuticals, which are currently being trialed for the treatment of epilepsy, diabetes, ulcerative colitis, schizophrenia and glioma.

Furthermore, GW Pharmaceuticals has filed a number of patents related to the medical uses of cannabis over the past decade. Their most recent patent was published in March 2013, entitled “Phytocannabinoids in the treatment of cancer” (US20130059018). In the patent, GW Pharmaceuticals outlined claims to the use of various marijuana-derived cannabinoids for the treatment of practically all forms of cancers, including “cancer of the prostate, breast, skin, glioma, colon, lung or a bone or lymph metastasis.”