Sativex is a natural marijuana extract developed by a British company, GW Pharmaceuticals. It is a liquid that is sprayed into the mouth. It’s made from marijuana plants bred by GW Pharma for specific levels of various active cannabinoids. It is similar to marijuana extracts and tinctures that were legally available in the US until 1937, after which they were banned by the federal government.
After announcing it’s launch in the UK for Monday, GW said it’s price, if sold by the National Health Service (NHS) would be 11 pounds ($16.3) per day when used as a prescription by Multiple Sclerosis patients to control spasticity. After 11 years in development and a history of previous delays, the launch has been well flagged by the company and it’s investors.
“It’s the first new treatment for spasticity in MS for over two decades, and it’s a product we know patients have long been seeking” GW’s managing director, Justin Gover, said in an interview on Monday, reported Reuters U.S edition.
Sativex became the world’s first medicine derived from whole plant extracts from the cannabis sativa plant to win regulatory clearance when Canada approved it in 2005 for neuropathic pain. It is comprised primarily of two cannabinoids extracted from marijuana, THC and canabidiol (CBD). The THC is known to cause the euphoric “high” but this side effect suppressed by the composition and delivery method of Sativex.
Although only currently available in Britain, Spain and Canada to MS patient’s who have had little or no success in controlling spasticity with traditional phamaceuticals, trials are being conducted in Spain to ease the side effects of chemotherapy for the treatment of cancer and combat malnutrition from AIDS and anorexia.
In 2007 GW and Otsuka Phamaceutical entered into and exclusive agreement for Otsuka to develop and market Sativex in the United States. They received permission from the US regulatory authority and the FDA to directly enter late stage trials in the US. Results were released in March. The randomized, double-blind, placebo controlled study was concluded very encouragingly. Dr. Steven Wright, GW’s R and D director said, “We are very pleased to have successfully completed phase II of studies supporting the efficacy of Sativex in Cancer pain, we are now working closely with Otsuka in preparing to develop phase III development of Sativex in the United States”
The current US development program anticipates two more Phase III trials prior to a subsequent submission of a New Drug Application to the FDA.
Will Sativex eliminate the need for Medical Marijuana? Absolutely not, Sativex acts far more slowly than marijuana that is inhaled. According to the company’s official product information, peak blood levels aren’t reached for more than an hour and half – about as slowly as Marinol, that some doctors and patient’s consider unacceptably slow. Sativex is also costly in addition to the simple fact that most patient’s respond better to different strains of marijuana for different situations and conditions. Sativex is just a different form of medical marijuana, and patient’s and doctors should be able to decide what works best for each patient’s particular situation.
If you are interested in learning more about Sativex please visit the GW FAQ page for detailed information on their grow procedures and policy or Marijuana Policy Project‘s web page for common questions and answers about Sativex.