Canada OKs cannabis oral spray

[Blondie]

http://money.cnn.com/2005/04/29/news/international/sativex/index.htm?cnn=yes

Unique painkiller for multiple sclerosis unlikely to win U.S. approval.

April 30, 2005: 7:27 PM EDT

By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - A cannabis-based painkiller for sufferers of multiple sclerosis is expected to be in Canadian pharmacies this summer, but whether it appears on U.S. pharmacy shelves is a key question.

Sativex, which is sprayed into patients' mouths, is produced by the British firm GW Pharmaceuticals. It was approved by the Canadian government on April 19.

"A great number of multiple sclerosis sufferers have experimented, sometimes illegally, with herbal marijuana in the past," said Mark Rogerson, spokesman for GW Pharmaceuticals, whose scientists extract cannabis from greenhouse-cultivated plants. "We are confident that many patients will prefer a pharmaceutical or a scientific solution to the problem rather than crude herbal marijuana."

The manufacturer has partnered with Bayer, the German drug giant, to get Sativex to the Canadian market as quickly as possible. Bayer (up $0.98 to $32.25, Research) also has a contract to market the drug in the United Kingdom, where it is awaiting approval by British authorities.

"Also this year, we are beginning the process of seeking approval for a medicine in the U.S.," says Rogerson. "We are in the early stages of talking to the U.S. administration."

Rogerson said his company would also be seeking approval in continental Europe. "If you get your approval in one EU country then you hit the ground running in other EU countries," said Rogerson.

In the United States, there are 400,000 people diagnosed with multiple sclerosis, compared to 50,000 in Canada and about 85,000 in Britain. Roughly half of these people suffer neuropathic pain that could be treated by Sativex, according to the companies.

'This is a very important opportunity for us," said Doug Grant, spokesman for Bayer Canada who declined to provide sales estimates. "There are very few opportunities where you can provide a drug where there is no other treatment available. There's no specific drug on the market for treating neuropathic pain for multiple sclerosis."

The first legal hurdle was cleared in 2001, when Canadian regulators approved medicinal marijuana for patients with multiple sclerosis, spinal injuries, AIDS, cancer and any terminal illness with a prognosis of less than 12 months to live.

But if the past is any indication, the U.S. Food and Drug Administration might go tough on a cannabis-based drug.

"Generally, physicians do not like to use narcotic-based drugs or drugs that have addictive-type characteristics for treatment of chronic pain," said Dr. John Richert, vice president for research and clinical programs for the National Multiple Sclerosis Society.

"There is not yet solid scientific evidence that the cannabis-related drugs are useful for multiple sclerosis pain," he said. "I think if there were solid scientific evidence that this type of drug helped, then that would be the evidence for the FDA to consider in their evaluation for the drug."

More than 10 states in the U.S. have approved legislation supporting the use of medicinal marijuana. But the federal government supersedes all state legislation and the FDA lists marijuana as an illegal narcotic.

GW Pharmaceuticals hopes the FDA will see Sativex differently from its recreational cousin. In addition to multiple sclerosis, Rogerson said, the painkiller is also being tested to treat rheumatoid arthritis, spasticity, spinal injuries and bladder dysfunction.

And unlike the herbal version of marijuana, Rogerson said Sativex is sprayed into the mouth in a liquid form and poses no threat to the lungs.

"Smoking is bad for you," said Rogerson. "You don't have to take my word for that. Just look a package of cigarettes and see what it says. We don't regard smoking as an acceptable method of delivery for a medicine."

Sativex differs from Marinol, an FDA-approved drug containing the active ingredient found in marijuana, because Sativex is extracted from a plant while Marinol is synthetic. Marinol is taken as a pill to fight appetite loss by patients with HIV or cancer patients undergoing chemotherapy.

*****

Wonder if they will have this spray for those of us who suffer with Lupus? Would certainly make this chemo thing more tolerable!!

:D

Blondie

[Thiebear]

I don't see how they can stop the spray.

It removes everything that is wrong with smoking the tar laden joint/bong/bowl/apple or in that one kids case.. skull..

[chomerics]

"Generally, physicians do not like to use narcotic-based drugs or drugs that have addictive-type characteristics for treatment of chronic pain," said Dr. John Richert, vice president for research and clinical programs for the National Multiple Sclerosis Society.

Oh really? Funny, because I have known a NUMBER of people who were on pain narcotics for various injuries and ailments. Vallium, darvocet, percocet, morphine, codine, oxycontin, vicodin are ALL addictive narcotics and they are prescribed daily to millions of people. Marijuana is NOT addictive, yet they use this as an excuse as to why it is not legal

"There is not yet solid scientific evidence that the cannabis-related drugs are useful for multiple sclerosis pain," he said. "I think if there were solid scientific evidence that this type of drug helped, then that would be the evidence for the FDA to consider in their evaluation for the drug."

Completely false testimony. There is in fact direct evidence that MJ helps out people with MS and also people suffering from the effects of chemotherapy. Their reasoning is because there is no "scientific evidence. This is because the federal government will not allow any case studies on the topic. There have been many documented cases where MJ has led to a remarkable transformation in people with MS and suffering from cancer, but they neglect to mention it because it was a study done outside of the US.

More than 10 states in the U.S. have approved legislation supporting the use of medicinal marijuana. But the federal government supersedes all state legislation and the FDA lists marijuana as an illegal narcotic.

Exactly why there has been no case studies inside the US, because it is illegal. . .

Now that I read this, it did get me thinking though, and this MAY be the way to get to the federal government. I know they dont care for their citizens, but they do care for drug companies, if there is a large profit to be made on this drug, there is a good chance that our government will reverse its outlandish policy on MJ and give it to drug companies in terms of a cash windfall Maybe there are a couple of stoners at Bayer and they've figured out the best way to legalizing MJ is through the campaign donations of drug companies

[Blondie]

Originally posted by chomerics

Oh really? Funny, because I have known a NUMBER of people who were on pain narcotics for various injuries and ailments. Vallium, darvocet, percocet, morphine, codine, oxycontin, vicodin are ALL addictive narcotics and they are prescribed daily to millions of people. Marijuana is NOT addictive, yet they use this as an excuse as to why it is not legal

Many years ago, I was thrown from a horse and the bottom 4 vertebrae in my back shifted.

The doctor put me on percodan.

I lost an entire summer. I have no memory of the months of June through August.

I had to be weaned from this drug.

I know peopel who use MJ for their bouts with chemo.

These old pesky drug tests.

:doh:

Blondie

[ChocolateCitySkin]

Talk about federal government... I read one person's description of his neuro pathic disease-- Like being plugged into an electrical socket 24/7. All the poor guy wants is for this drug...

Don't understand why the feds fight this one so hard. Specially since there are 11 states that have legalized medical marijuana. Seems like a losing battle that they're just wasting our tax dollars on. I mean honestly, how many MS/cancer patients do you want to incarcerate?

[ChocolateCitySkin]

Originally posted by chomerics

Now that I read this, it did get me thinking though, and this MAY be the way to get to the federal government. I know they dont care for their citizens, but they do care for drug companies, if there is a large profit to be made on this drug, there is a good chance that our government will reverse its outlandish policy on MJ and give it to drug companies in terms of a cash windfall Maybe there are a couple of stoners at Bayer and they've figured out the best way to legalizing MJ is through the campaign donations of drug companies

Unfortunately, its a british company called GW Pharmatceuticals-- Our companies are produce a synthetic version called Marinol that makes people even more sick...