Canada To Allow Cannabis-Based Medicine

Sativex Comes To North America: Canada Gives Preliminary Approval Of Cannabis-Based Drug

Canadian health officials have given preliminary approval for testing of the GW Pharmaceuticals drug Sativex. The Wall Street Journal reported on Feb. 8, 2005 ( "Medical Marijuana Gets Backing In Canada") that "Medical marijuana has been winning legal endorsement through the efforts of a British pharmaceutical firm. GW Pharmaceuticals of Salisbury, England, has spent years developing and promoting a cannabis-based mouth spray that the company claims eases severe pain and muscle stiffness without causing a psychotropic high. Winning the backing of health authorities has been an uphill battle, but Canadian officials recently gave it preliminary approval for treatment of neuropathic pain in multiple sclerosis sufferers. Studies concluded not long ago also showed the product effective at treating severe cancer pain. Now GW is aiming for approval in the United Kingdom, and longer-term, in the U.S., where medical marijuana is likely to come up against greater resistance. 'The deepness and polarity of the [marijuana] debate in the U.S. is unique,' acknowledges Geoffrey Guy, executive chairman of GW. GW hopes the Canadian approval 'will force the U.S. to address this issue once and for all and make a decision,' says Managing Director Justin Gover. If the product is approved in more markets, GW believes it one day could be used by a million patients suffering from pain associated with MS, cancer and other ailments."

According to the Journal, "The treatment, called Sativex, is an extract of a hybrid form of cannabis grown by GW. The company says the plants are specially bred to remove most of the psychotropic agents and to increase the presence of helpful properties such as cannabidiol. The company, which won a special license from the U.K. to breed cannabis and carry out research, grows 50,000 plants every year in greenhouses in a location it keeps secret so as to avoid curiosity seekers, protesters and potheads. Founded in 1998 to research the medicinal uses of cannabis, GW is traded on the London Stock Exchange. The company has a few other cannabis-derived products in early development."

As noted in the English publication New Scientist on Feb. 5, 2005 ( "Prescribing The Miracle Weed"), "Many patients with difficult-to-treat conditions use cannabis to relieve their symptoms, but in most parts of the world that makes them criminals. Otherwise law-abiding citizens dislike having to get their treatments from drug dealers. And the quality of the medication they get that way is variable to say the least. But in the next few weeks Canadian regulators will decide whether to approve an under-the-tongue cannabis spray called Sativex for multiple sclerosis ( MS ) patients. As the world's first prescription pharmaceutical made from marijuana, it would at last allow patients to get their therapy in a safe and consistent formulation. The product could become available in the UK in a year or so, and its British manufacturer, GW Pharmaceuticals, is expected to file for approval soon in Australia and New Zealand. Sativex will not bring any miracle cures, and in countries like the US where official hostility to marijuana is ingrained, patients may have a longer wait for its benefits. All the same, the availability of a cannabis preparation as a prescription medicine will mark a milestone in a decades-long battle by doctors and patients for public acceptance of medical cannabis use."

Indeed, as New Scientist notes, "It may not be long before Sativex is joined by other cannabis preparations. A non-profit group, the Institute for Clinical Research in Berlin, Germany, is developing oral cannabis capsules, called Cannador. In November 2003 a study in 630 MS patients produced equivocal results ( The Lancet, vol 362, p 1517 ). While the formal scoring system for measuring muscle spasticity indicated that Cannador performed no better than a placebo, the patients themselves felt it helped. Martin Schnelle, who conducted the trial, says that there are widely acknowledged problems with the formal scoring system used. 'There are medicines that are already licensed for treating spasticity that have failed on this scale,' he says. The group is planning a further study this year in which the patients' reports will be the main measure by which the drug's effectiveness is judged."