Marijuana mouth spray seeks FDA approval as painkiller

A sample of the GW Pharmaceuticals' drug Sativex is shown.

/ AP

(CBS/AP) A marijuana-based mouth spray may get FDA approval as soon as 2013 - at least that's what British manufactuer GW Pharma hopes. The company is in advanced clinical trials on the world's first pharmaceutical developed from raw marijuana plants.

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Other marijuana-based drugs currently on the market use synthetic equivalents of pot, but this stuff's made from the real deal. Its makers want to market the drug in the U.S. as a treatment for cancer pain.

The spray, called Sativex, contains marijuana's two best known components - delta 9-THC and cannabidiol. The medication has already been approved in Canada, New Zealand and eight European countries for relieving muscle spasms associated with multiple sclerosis.

If the FDA approves the spray, it would represent an important milestone in the U.S., which has had a sticky history with medical uses of marijuana. Currently, 16 states and Washington D.C. allow residents to legally use medical marijuana with doctors' recommendations. The U.S. Drug Enforcement Administration considers pot a dangerous drug with no medical value, subjected it to federal prosecution. But the availability of a chemically similar prescription could increase pressure on the federal government to revisit its position.

"There is a real disconnect between what the public seems to be demanding and what the states have pushed for and what the market is providing," said Aron Lichtman, a Virginia Commonwealth University pharmacology professor and president of the International Cannabinoid Research Society. "It seems to me a company with a great deal of vision would say, 'If there is this demand and need, we could develop a drug that will help people and we will make a lot of money.'"

Possessing pot is also still illegal across the pond in the U.K., but about a decade ago GW Pharma's founder, Dr. Geoffrey Guy, received permission to grow it to develop a prescription drug. Guy proposed the idea at a scientific conference that heard anecdotal evidence that pot provides relief to multiple sclerosis patients, and the British government welcomed it as a potential way "to draw a clear line between recreational and medicinal use," company spokesman Mark Rogerson said.

"We were the first ones to charge forward and a lot of people were watching to see what happened to us," Rogerson said. "I think we are clearly past that stage."

In 1985, the FDA approved two pills containing synthetic THC, Marinol and Cesamet, to ease side-effects of chemotherapy in cancer patients. The agency eventually allowed Marinol to be prescribed to stimulate the appetites of AIDS patients. The drug's patent expired last year, and other U.S. companies have been developing formulations that could be administered through dissolving pills, creams and skin patches and perhaps be used for other ailments.

Doctors and people with multiple sclerosis patients are cautiously optimistic about Sativex. The National Multiple Sclerosis Society has not endorsed marijuana use by patients, but the organization is sponsoring a study by a University of California, Davis neurologist to determine how smoking pot compares to Marinol in alleviating painful muscle spasms.

Interest in new and better marijuana-based medicines has been building since the discovery in the late 1980s and 1990s that mammals have receptors in their central nervous systems, several organs and immune systems for the chemicals in botanical cannabis and that their bodies also produce natural cannabinoids that work on the same receptors.

One of the first drugs to build on those breakthroughs was an anti-obesity medication developed by Sanofi Aventis called Acomplia that blocked the same chemical receptors that trigger the munchies in pot smokers. Acomplia was approved throughout Europe and heralded as a possible new treatment for smoking cessation and metabolic disorders that can lead to heart attacks.

The FDA was reviewing its safety as a diet drug when follow-up studies showed that people taking the drug were at heightened risk of suicide and other psychiatric disorders. Sanofi pulled it from the market in late 2008.

Given that drug companies already were reluctant "to touch anything that is THC-like with a 10-foot- pole," the setback had a chilling effect on cannabinoid drug development, according to Lichtman.

He said, "Big companies like Merck and Pfizer were developing their own versions (of Acomplia), so all of those programs they spent millions and millions on just went away..."

[kevin_hunt]

Legal hash oil...cool!

[rixt53]

It is unfortunate that the law enforcement community is so addicted to interdiction funding. The billions spent every year in the U.S. on cannabis interdiction may well be the biggest reason the laws have not been changed. Of all anti-drug funding, about half is spent on cannabis enforcement. The costs of prosecution, imprisonment and probation/parole supervision are also ridiculous. When the cops can confiscate your car if they catch you with a joint, they are going to campaign against any legalization or decriminalization efforts. When Federal Government drug interdiction grants fund positions on the police force, what cops are going to favor the disappearance of those funds? The drug laws in this country are utterly ridiculous, not to mention unconstitutional. Nonetheless, don't expect any changes anytime soon. Support NORML and LEAP!

[JamesSReed]

I don't understand, the DEA and congress say marijuana has no medical uses, that's why it's in the same schedule as heroin and LSD, how can people use it as medicine when the government says it's poison? When I was a kid, a police man came to my class and said "If you smoke a marijuana joint it can kill you dead". Aren't all the people who use these drugs dying? I'm so confused...
Barack Obama, tell us what to do!

[karek40]

Naive, its all about the money. Legalize it and the money disappears.

[pfroehlich2004]

If you want to end marijuana prohibition in Connecticut, please visit www.ctprimaryproject.com.

Please pass this on to anyone you know in Connecticut!

[peaceandloveplease]

why cant we just smoke it?

[kesterling2003]

Who's stopping you?

I'd recommend that you seriously consider not smoking. I quit in 2006 and have never looked back. There are just too many other delivery methods which don't require the person enjoying cannabis or utilizing it for medicinal to inhale carbon monoxide. The vaporizer is proven safe, less expensive, and preferred by the study's subjects by a margin of 7:1 in peer reviewed research published in 2007. No carbon monoxide or other nasty byproducts of smoking are produced when the vaporizer is set at the optimal temperature. One other benefit of the vaporizer is personal safety. Do you realize how many people get arrested every year because an LEO smelled the odor of burning cannabis? Things would have been different for those people if they had stuck with a vaporizer, oromucosal delivery via tincture or gel strip, infused edibles/liquids, eye drops or suppositories.

Link to research study above in the next post if the censor let's it happen. Otherwise Google +CMCR +vaporizer +Abrams to find it.

[claygooding]

After 25 years of attempting to make a synthetic marijuana pill the gave up and went ahead and used the plant,,,,and all these "future" uses,,the same ones people in 16 states are using medical marijuana for now,,,and the drug czar telling America has no medical uses.

Sounds like standard government operating procedure.

At least this time a black market will develop for this one,,the last few attempts of making medicine from marijuana were so poor a black market has never developed for them. Do you know how disappointed the makers of Marinol must be?

[legalizemj]

Legalizing cannabis pills while keeping natural cannabis illegal is like legalizing vitamin-C while making oranges illegal. It lacks logic, it lacks science and it creates significantly more harm than good. We can drive the drug dealers off the street and make our children significantly safer by legalizing adult cannabis sales.

States that have passed medical marijuana laws have seen a 9% drop in alcohol-related traffic fatalities. We can save a LOT of lives by giving people the right to substitute marijuana for alcohol.

Marijuana has repeatedly been proven to NOT cause cancer, heart disease, brain damage, liver disease, emphysema, or any other significant health issue, and its addiction potential is about on par with coffee. We mustn't wait until a loved one has been harmed by alcohol before demanding that our legislators legalize adult marijuana sales!