GW announces that Sativex® has been granted regulatory approval in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis. Dr Geoffrey Guy, Executive Chairman, said, “We are delighted that Sativex has received regulatory approval in Canada. This event marks the world’s first approval of a cannabis derived medicine. This first regulatory approval has been obtained by GW in just over six years since the Company’s development programme commenced, a highly significant achievement. We are now working with our Canadian marketing partner, Bayer, towards the launch of Sativex throughout Canada in late Spring.”

The full text of a joint statement (no pun intended) released today with Bayer Healthcare, follows below:

HEALTH CANADA FIRST TO APPROVE A NOVEL CANNABIS DERIVED PHARMACEUTICAL TREATMENT FOR PEOPLE WITH MULTIPLE SCLEROSIS TORONTO, Ontario – (19 April 2005)

– Health Canada has approved Sativex® (Cannabis sativa L. extract) a new drug developed as adjunctive treatment for the symptomatic relief of neuropathic pain in adults with multiple sclerosis (MS). Canada becomes the first country in the world to approve Sativex, a novel prescription pharmaceutical product derived from components of the cannabis plant shown to have therapeutic properties. Sativex is administered via a spray into the mouth.

Health Canada has approved Sativex with conditions, under the Notice of Compliance with Conditions (NOC/c) policy. This authorization reflects the promising nature of the clinical evidence which will be confirmed with further studies. Products approved under Health Canada’s NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use.

“Effective pain control and management are extremely important in a disease like MS,” said Dr. Allan Gordon, Neurologist and Director of the Wasser Pain Management Centre, Mount Sinai Hospital, Toronto, Ontario. “The approval of Sativex in Canada reflects the urgent need for additional treatment options in the field of neuropathic pain in MS.”

Neuropathic pain Pain is a common symptom of MS occurring in up to 86 per cent of people with MS. 1 Neuropathic or nerve pain can occur spontaneously or can be provoked by touch, temperature or movement. It is estimated that 50 per cent of people with MS suffer from chronic neuropathic pain. 2,3,4 The most common descriptions of neuropathic pain are of freezing, cold or burning sensations usually of the limbs and most often of the lower extremities.5 Many individuals with neuropathic pain respond inadequately to current treatment options.6,7

“It’s hard to explain to someone who has never felt this type of pain. It’s like being plugged into an electric socket all the time,” said Steve Walsh, who suffers from MS and has lived with neuropathic pain for five years. “At times, putting on clothes or anything touching me can be too much to take,” he added.

Data demonstrates efficacy While there is no complete cure for MS or neuropathic pain, a double-blind placebo controlled parallel group study demonstrated that Sativex provided significantly greater pain relief than placebo. Sativex also significantly reduced pain-related sleep disturbance.

Principal components A product resulting from the pioneering research efforts of UK-based GW Pharmaceuticals plc and marketed in Canada by Bayer HealthCare, Pharmaceuticals Division, Sativex is the first product indicated in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in MS.

Its principal active cannabinoid components are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The ratio of THC to CBD in Sativex is 2.7 mg : 2.5 mg per spray, ensuring a standardized dose is delivered each time it is used.

“The approval of Sativex is good news for the Canadian MS community. People living with MS and neuropathic pain need new options to address their pain. Sativex will likely be welcomed by the many people with MS, whose quality of life has been further compromised with neuropathic pain,” said Dr. William J. McIlroy, National Medical Advisor, MS Society of Canada.

How Sativex works Sativex is administered through a spray pump under the tongue or on the inside of the cheek, providing reliable, self-administered pain relief. The spray formulation allows for more flexible dosing than an oral tablet, well suited to the variable nature of neuropathic pain experienced by people with MS.

“Because Sativex is designed for self-administration, this allows for flexible dosing and puts the patient in control of their pain,” said Dr. Gordon. “This is very important since pain severity varies between different patients and even in the same patient at different times.”

Sativex and side-effects In clinical trials, the most frequent side-effects included nausea, fatigue, dizziness and application site reactions. Side-effects were usually mild or moderate in severity and often resolved with down-titration or interruption of treatment.8

Sativex is expected to be available through Canadian pharmacies by late Spring 2005.

Multiple sclerosis (MS) in Canada9 MS is a disease of the central nervous system and is the most common neurological disease affecting young adults in Canada. Approximately 50,000 Canadian men and women have the disease and each day approximately three more people are diagnosed. MS is most often diagnosed in people between the ages of 20 to 40 years of age.

HempPharm.com comment; Cannabis and Marijuana whole extract is legal and natural marijuana somehow is not? How is this possible? In any case the official status of Medical Marijuana has been confirmed by the Canadian (medical) establishment. Hooray!

By Rob Kampia, AlterNet Source: AlterNet 4/19/05

By approving liquid marijuana, the Canadian government has just certified that virtually everything our own government has been telling us about marijuana is wrong. On April 19, the Canadian government delivered what should be the final blow to the U.S. government's irrational prohibition against the medical use of marijuana. It approved prescription sale of a natural marijuana extract -- for all practical purposes, liquid marijuana -- to treat pain and other symptoms caused by multiple sclerosis.

Sativex, produced by GW Pharmaceuticals in Britain, brings the medical marijuana debate full circle. Though the technology has advanced in 70 years, this product is a direct descendent of the marijuana extracts and tinctures that were a standard part of the medical armamentarium until the late 1930s -- universally recognized as being safe and effective for certain conditions. These products were taken away from patients and doctors as a result of the prohibition on marijuana that began in 1937, despite the public opposition of the American Medical Association.

In short, the Canadian government has just certified that virtually everything our own government has been telling us about marijuana is wrong. In defiance of a large and growing pile of scientific studies, our government still claims that marijuana has no medical value. White House Drug Czar John Walters even compared medical marijuana to "medicinal crack."

Such statements were always scientifically ridiculous, as has been noted by a wide range of authorities, including the American Public Health Association, the American Nurses Association, and the state medical societies of New York, California and Rhode Island, to name just a few. Now, GW Pharmaceuticals' research has definitively put such nonsense to rest.

Make no mistake: Sativex is liquid marijuana. It is nothing like Marinol, the synthetic THC pill sold in the U.S. and sometimes falsely touted as an adequate substitute for marijuana.

Sativex is a whole-plant extract, containing the rich variety of naturally occurring compounds called cannabinoids that are unique to marijuana. It also contains trace elements of other compounds contained in the plant, which scientists believe contribute to its therapeutic value.

On its website, GW Pharmaceuticals explains, "We believe very strongly that many of the advantages of using the whole plant come from the inclusion of other components of cannabis [marijuana]," not just THC. "In the cannabis plant, it appears that some of the components added together give better effect. Some components seem to work to counteract some of the side effects of others, and the whole plant is generally well tolerated by humans."

Sativex is to marijuana as a cup of coffee is to coffee beans. If Sativex is safe and effective, marijuana is safe and effective. And Sativex is safe and effective. Studies have shown significant effect against pain and other symptoms caused by multiple sclerosis and other debilitating conditions. Over 600 patient-years of research have established a remarkable record of safety.

Sativex should certainly be approved in the U.S., but the process may take years -- if it is allowed to happen at all. Sadly, our government's reflexive hostility to the medical use of marijuana shows no sign of abating.

But an even larger issue looms: Now that we know beyond doubt that marijuana is a safe, effective medicine, how long will our government continue to arrest patients who use it?

And even if Sativex is approved here someday, it won't be the answer for every patient now benefiting from medical marijuana. For one thing, it has been clearly shown that different strains of marijuana -- with different blends of cannabinoids -- work better for some conditions and less well for others. Sativex just comes in one formula, and it won't be right for everyone.

And Sativex will be expensive. Will we force patients to buy a pricey pharmaceutical version of a plant they could grow themselves for pennies? At a time when our health care system is drowning in rising costs, that's insane. We could end up with a policy every bit as silly as telling coffee drinkers that they can buy a cappuccino, but they'll be arrested on sight if caught in possession of coffee beans.

The lesson of Sativex is simple: Our government was wrong. Marijuana is medicine, and patients and doctors should be able to use it in whatever form works best for their particular situation.

Rob Kampia is executive director of the Marijuana Policy Project in Washington, DC.

Please also read: Long Term Exposure To Cannabis