cannabisnews.com: GW Wins U.S. Okay for Pivotal Cannabis Drug Study










  GW Wins U.S. Okay for Pivotal Cannabis Drug Study

Posted by CN Staff on January 03, 2006 at 20:23:09 PT
By Ben Hirschler 
Source: Reuters 

London -- GW Pharmaceuticals Plc has won approval from U.S. regulators to conduct a pivotal Phase III study into its cannabis-based medicine Sativex as a treatment for cancer pain, the British drug company said on Wednesday.GW expects to start testing the product, which is sprayed into the mouth, in U.S. patients with advanced cancer later this year.
The randomised clinical trial will involve 250 people and is likely to last between 24 and 36 months, suggesting Sativex will not be ready for launch in the U.S. marketplace until towards the end of the decade.Canada became the first country in the world to approve Sativex in April 2005, for the relief of neuropathic pain in patients with multiple sclerosis.GW suffered a setback three weeks ago, however, when a British inquest found the death of a patient taking Sativex in an earlier clinical study was probably linked to the medicine.Sativex is GW's leading product and the source of most of the company's value.The group grows thousands of marijuana plants at a secret location in the English countryside, having been granted a dispensation by the government to use the plant for medical research.Geoffrey Guy, GW's executive chairman, said the acceptance of the Phase III study application by the Food and Drug Administration was a significant achievement for the company that would compress the overall length of time needed to win U.S. approval by avoiding the need for earlier-stage trials.Having the product in final tests should also strengthen GW's hand in negotiations with potential partners in the United States, where it has yet to sign up a marketing ally.Germany's Bayer AG is GW's marketing partner in Canada and Britain, while Almirall of Spain recently agreed to market the drug in European countries excluding Britain.Cannabis has a long history of medicinal use, dating back to ancient Chinese times. Queen Victoria, whose physician described it as "one of the most valuable medicines we possess", is said to have taken cannabis tincture for her menstrual pains.It fell out of favour in the 20th century because of a lack of standardised preparations and the development of more potent synthetic painkillers.GW says it has got round those standardisation problems with its spray-based product, which also avoids the damaging effects of smoking the drug. Source: Reuters (Wire)Author: Ben HirschlerPublished: January 4, 2006Copyright: 2006 Reuters Related Articles & Web Sites:GW Pharmaceuticalshttp://www.gwpharm.com/Spray Alternative To Pot On The Market in Canadahttp://cannabisnews.com/news/thread20893.shtmlThe Lesson of Sativexhttp://cannabisnews.com/news/thread20542.shtml

Home    Comment    Email    Register    Recent Comments    Help





Comment #32 posted by FoM on January 06, 2006 at 12:25:18 PT
Whig
Wisconsin sounds like a great place. California is beautiful but in Wisconsin all you have is snow but no earthquakes and mudslides. Buy a couple parkas and you're good to go!
[ Post Comment ]


Comment #31 posted by whig on January 06, 2006 at 12:19:19 PT
FoM
It's really based on where my wife will be going to graduate school, and we aren't going to know where she's accepted until February at the earliest. Among others, two of the schools she's applied to are in California and one is in Wisconsin (apart from the weather, I hear Madison's a great town).
[ Post Comment ]

 


Comment #30 posted by FoM on January 06, 2006 at 11:37:11 PT

whig
A little advice. Check out job opportunities in the states that have lowered the penalties and the cost of rent in those states. That could help you narrow it down. Good luck to you and your wife.
[ Post Comment ]


 


Comment #29 posted by whig on January 06, 2006 at 10:31:00 PT

Toker00
Where I live presently, cannabis is still very much not in the mainstream culture, and it is not something to be discussed publicly for the most part.I will be moving in a few months (around summertime), though I don't know exactly where yet. It would be nice if we wind up in a community that is more tolerant but this is a decision my wife and I will be making once we know what our options are.
[ Post Comment ]


 


Comment #28 posted by Toker00 on January 06, 2006 at 09:25:14 PT

Gen X
Whig, so is my nephew. He's a stoner, but a bit afraid to profess it anyplace, even cyberspace. And certainly not in public. He was brought up in a lot more comfortable situation than I was, so he probably thinks he has more to lose. He wasn't much of a rebel or dare-devil. He's a good man, though. Wage peace on war. END CANNABIS PROHIBITION NOW! 
[ Post Comment ]


 


Comment #27 posted by whig on January 05, 2006 at 19:08:16 PT

Toker00
I'm actually at the upper end of Gen-X myself.
[ Post Comment ]



 


Comment #26 posted by FoM on January 05, 2006 at 15:11:53 PT

Toker00 
I sure agree with you. We are just coming into our own. I am 58 so I'm on the upper end of the boomers but I still am very aware of how all the good we wanted was pushed aside by the powers that be. Now we have clout. Boomers are over 25 percent of the whole US population. We went our merry way and did our own things in life but we didn't forget our ideals.Come on people now smile on your brother everybody get together try to love one another right now!
[ Post Comment ]



 


Comment #25 posted by Toker00 on January 05, 2006 at 14:56:32 PT

Weak position?
"And having emphasized the sympathetic claims of suffering patients for so long, they will be in a weak position to argue that people shouldn't need a special excuse to smoke pot." I think the author really means, "Special Excuse to End Cannabis Prohibition" instead of "smoke pot".That is so shallow. There are so many reasons beyond medical use to liberalize Cannabis. We have been stating them for decades. We have been yelling them from the streets and the rooftops. This is a very weak statement to support prohibition. Most of us boomers know the rejuvenating, and re-vitalizing power of Cannabis/hemp. We are only now entering the thresholds of political power in this nation. Look what we did as teenagers and very young adults in the sixties/seventies. With our maturity has come a far more potent law changing power than we had thirty years ago, though it was awesome then. We listened to each other then and made great changes in social law and common attitudes. We got very loud, and made other people listen, too. Once the people actually started hearing what we were saying, the movement became energized, just as it is about to become, again. What these people don't understand is, we are about much, much more than just "Legalizing" Cannabis. We intend to make changes not just in the drug laws in this country, but the domestic and foreign policies, as well. Think about it. The oldest boomers are in their sixties. The youngest are in their forties. Most Politicians don't come into their real power until they are fifty/sixty +. We are at the edge of a new dawn. The next twenty years will be most interesting, I predict.And remember, the younger geneation has embraced most of our ideals. They even like our music. And they certainly love Cannabis. We got back-up.Wage peace on war. END CANNABIS PROHIBITION NOW! 
[ Post Comment ]



 


Comment #24 posted by FoM on January 05, 2006 at 14:32:41 PT

Hope
I understand what you mean. I really avoid Reason Magazine any more because they are more like the LP and when I first went to their site they said they weren't involved with any political party and that is why I avoid them. I will never think like a Libertarian. It's a guy organization and I am liberal when it comes to women having equal rights with men but it doesn't seem to be that way with them. It just is personal with me but I understand what you are saying.
[ Post Comment ]



 


Comment #23 posted by Hope on January 05, 2006 at 14:18:34 PT

FoM
I was commenting on the statement in the Reason article. "Once legal, equally effective aternatives to marijuana are readily available, reformers will be forced to switch their focus back to recreational use (which is, after all, the main form of marijuana consumption), seemingly confirming the accusation that all their talk about the drug's medical virtues was just a cover. And having emphasized the sympathetic claims of suffering patients for so long, they will be in a weak position to argue that people shouldn't need a special excuse to smoke pot."The only "excuse" an adult has to have from anyone is, "I like it." and "Butt out." In other words...no "excuse" is necessary.And medical excuse marijuana use was never a "cover" for anything. It's was just the most pressing and urgent aspect of the need to legalize. People are suffering when they don't have to because of the the silly superstitions and hysterias and outright lies of the prohibitionists. We had to help the neediest first. I'd rather like to show them what "cover" means by making them feel the need to "cover" their proverbial rear end to keep the sensible among us from kicking it down the street and back, as it so well deserves.
[ Post Comment ]



 


Comment #22 posted by FoM on January 05, 2006 at 11:46:30 PT

Related Article from Snipped Source
FDA Lets Drugmaker Test Cannabis-Based Pain Spray ***Thursday, January 05, 2006Proponents of medical marijuana got a boost yesterday when the Food and Drug Administration gave a British drugmaker permission to test a cannabis-derived treatment for cancer pain. GW Pharmaceuticals was given permission to start a Phase III clinical trial in the United States for Sativex, an oral spray for use by seriously ill patients. The company said it may file for FDA approval as early as 2008. Currently, sufferers of severe cancer pain have only a handful of narcotic pain medications, such as morphine, oxycodone, hydromorphone and fentanyl. They have potentially serious side effects in up to 60 percent of patients. Snipped:Complete Article: http://tinyurl.com/8sgye
[ Post Comment ]



 


Comment #21 posted by FoM on January 05, 2006 at 11:26:57 PT

whig
Like Jack Herer said Hemp could save the world.
[ Post Comment ]



 


Comment #20 posted by whig on January 05, 2006 at 11:20:46 PT

FoM
Pot is medicine for the healing of the nations, too.:)
[ Post Comment ]



 


Comment #19 posted by FoM on January 05, 2006 at 11:06:10 PT

Hope
I don't disagree with you but I look at this wonderful plant as medicine. Medicine can be used just to make a person feel better. If Cannabis didn't make a person feel better no one would smoke it. We have all kinds of drugs just for the purpose of making a person feel better so why not this natural herb? I take St. John's Wort as an anti-depressent but I could get a script for Prozac. SJW is an herb and it's legal.
[ Post Comment ]



 


Comment #18 posted by Hope on January 05, 2006 at 10:58:27 PT

The best "excuse" anyone has
for smoking marijuana/cannabis is, "I like it." If I don't blow the smoke in your face or want to drive under the influence, you have no business telling me or any other adult that we have no right to use it. You don't have to like it, but to tell anyone else they can't like it, is ridiculous.The prohibition of cannabis is a huge and profitable scam. I don't like being scammed. I don't like seeing people persecuted, dehumanized, demonized, robbed, bound, humiliated, jailed, and murdered for using it.
[ Post Comment ]



 


Comment #17 posted by FoM on January 05, 2006 at 09:26:09 PT

afterburner 
I think like you. I don't read Reason anymore since I figured out they are a LP based news site. It takes me time to figure things out but after they wrote bad things about Kerry last year that ended my looking at their site at all.
[ Post Comment ]



 


Comment #16 posted by afterburner on January 05, 2006 at 09:18:22 PT

Balderdash and Poppycock to Reason Magazine
"special excuse to smoke pot"?Many cannabis consumers do so to prevent illness. This does not diminish their concern for brothers and sisters whose health is more compromised by chronic illness. And the body is also a mind, a soul, a spirit and healing cannabis unifies them in spiritual blessing.
[ Post Comment ]



 


Comment #15 posted by FoM on January 05, 2006 at 08:37:11 PT

Hit and Run from Reason Magazine
Medical Marijuana's Days Are NumberedJanuary 05, 2006 Yesterday GW Pharmaceuticals announced that it has received FDA approval for Phase III clinical trials of its cannabis extract spray, Sativex, which the Canadian government last year approved as a treatment for neuropathic pain in patients with multiple sclerosis. The U.S. study will test Sativex's effectiveness in treating the pain of cancer patients who do not get adequate relief from narcotics--an application that has shown promise in a European study. GW, which is based in the U.K., reports that the FDA let it skip Phase I and Phase II trials, which focus on establishing safety and appropriate dosage, because it had already conducted substantial research on Sativex in Europe.GW's success with Sativex, which is sprayed into the mouth, once again contradicts American drug warriors' repeated denials of marijuana's therapeutic utility. At the same time, it's another step toward a future in which legal alternatives to smoked, vaporized, or ingested whole cannabis will render the medical marijuana debate moot.Another such step is Philip Morris' medical inhaler, which is based on technology developed for its unsuccessful smokeless cigarette. The device delivers aerosol medicine to the lungs for quick absorption. If used with THC and/or other useful cannabinoids, it would have all the medical advantages of smoked marijuana (immediate action, patient control over dosage, no capsules to swallow and keep down) without the drawbacks (variable strength, combustion products). Such a product would be more expensive than homegrown or club-dispensed marijuana, but presumably it would be covered by insurance.These developments, while a boon to patients, wll pose a challenge to the drug policy reform movement, which has gotten a lot of mileage out of the federal government's cruel, know-nothing intransigence on the issue of medical marijuana. Once legal, equally effective aternatives to marijuana are readily available, reformers will be forced to switch their focus back to recreational use (which is, after all, the main form of marijuana consumption), seemingly confirming the accusation that all their talk about the drug's medical virtues was just a cover. And having emphasized the sympathetic claims of suffering patients for so long, they will be in a weak position to argue that people shouldn't need a special excuse to smoke pot. http://www.reason.com/hitandrun/

[ Post Comment ]



 


Comment #14 posted by Hope on January 04, 2006 at 16:16:47 PT

Cloud7, Comment 12
Right on!
[ Post Comment ]



 


Comment #13 posted by FoM on January 04, 2006 at 15:14:06 PT

cloud7
Thanks! 
[ Post Comment ]



 


Comment #12 posted by cloud7 on January 04, 2006 at 14:49:15 PT

...
"It fell out of favour in the 20th century because of a lack of standardised preparations and the development of more potent synthetic painkillers."There was a mistake in this article, I fixed it below:"It fell out of favour in the 20th century because of a smear campaign headed by the Harry Anslinger and the need to provide jobs for the agents who lost them once alcohol prohibition was lifted."
[ Post Comment ]



 


Comment #11 posted by FoM on January 04, 2006 at 12:46:50 PT

Pot-Based Drug OK’d for Tests
January 4, 2006Portion of article:Thousands of Marijuana PlantsGW manufactures the drug from thousands of marijuana plants it has been granted special permission to cultivate at a secret location in the English countryside. It says the spray-based formulation avoids the damaging effects associated with inhaling marijuana smoke.Complete Article: http://tinyurl.com/c3ymt

[ Post Comment ]



 


Comment #10 posted by FoM on January 04, 2006 at 07:31:41 PT

Two Comments
I only found out this morning that the miners didn't make it and I feel so sad for the families and I watched Walters on C-Span.Is it time to follow the money closer when it comes to who could be helping keep Cannabis illegal?
[ Post Comment ]



 


Comment #9 posted by BGreen on January 04, 2006 at 07:06:28 PT

Crude = Andrea Barthwell
That's obviously her influence in GW Pharmaceutical's US marketing plan, because that was her favorite derogatory "qualifier" for anytime she tried to differentiate between marinol and the cannabis plant.I'm really disgusted with their lies.Sativex can still be marketed without disparaging the cannabis plant with venomous prohibitionist lies, but apparently GW Pharmaceuticals feels it must go to bed with the devil to get their product approved.The Reverend Bud GreenFor her part, Barthwell has refused to publicly comment about her turnaround, except to say to the Los Angeles Times that "comparing crude marijuana to Sativex is like comparing a raging forest fire to the fire in your home's furnace. While both provide heat, one is out of control."http://www.cannabisnews.com/news/21/thread21203.shtml"Having this product available will certainly slow down the dash to make the crude plant material available to patients across the country," said Barthwell, an addiction medicine specialist.http://www.cannabisnews.com/news/20/thread20549.shtmlBarthwell believes there's great potential for future medicines developed from the compounds in marijuana plants, but she's against legalizing the whole plant for medical ( or any other ) use. "People have to ask themselves, as they sort of glom on to this whole argument about 'Let's make this crude weed a medication,' is this really the one plant that the great maker put on this earth that's going to cure everything that ails us-the first real magic bullet in this form-or is it a cruel hoax that exploits our compassion for the sick and dying?" she asks. "It certainly looks like it's got the potential to be a cruel hoax, because a crude plant is definitely not medicine."http://www.cannabisnews.com/news/20/thread20249.shtml
[ Post Comment ]



 


Comment #8 posted by Hope on January 04, 2006 at 05:19:25 PT

Crude?
"...crude herbal cannabis".I prefer the term "perfect". As in "perfect herbal cannabis".
[ Post Comment ]



 


Comment #7 posted by kaptinemo on January 04, 2006 at 05:09:01 PT:

"Like comparing apples to...apples?"
Sativex is liquid cannabis. Period. It doesn't matter from what strain it is derived, it doesn't matter if it was grown by 'hydro' or outside, it doesn't matter how it's reblended, it's...*still*...CANNABIS! If I take apples and grind them up into applebutter, it's still comprised of apples. No amount of fancy spinning can deflect this fact. This is not 'apples and oranges, it's 'apples and apples'. The difference of course, is that the 'apples' will come in a fancy spray bottle with some Gub'mint bureaucrat's stamp of approval on it and you get charged out the nose for it. The brazeness of Big Pharma knows no bounds.
[ Post Comment ]



 


Comment #6 posted by BGreen on January 03, 2006 at 23:00:38 PT

I beg to differ on the rescheduling question
Sativex is a whole-plant extract, not a laboratory produced chemical compound.This makes Sativex no different than any other whole-plant cannabis extract, provided they are similar in their cannabinoid profile.I think the cat has been let out of the bag and the government is about to be scratched.The Reverend Bud Green
[ Post Comment ]



 


Comment #5 posted by FoM on January 03, 2006 at 21:05:55 PT

duzt 
That's not fair.
[ Post Comment ]



 


Comment #4 posted by duzt on January 03, 2006 at 21:03:18 PT

FOM, it won't get rescheduled for Sativex...
Here's a question and answer from GW Pharma,
"Must cannabis be rescheduled (out of Schedule 1 of the US Controlled Substances Act) in order for Sativex® to be approved as a prescription medicine in the US?""No, contrary to the statements of certain cannabis advocates, Sativex® will be available on prescription in the US only when it has satisfied the FDA’s standards for quality, safety, and efficacy and meets the relevant Drug Enforcement Administration registration requirements for such an approved product. Cannabis’s placement in Schedule 1 has no effect on the fact that Sativex® must satisfy the FDA’s regulatory requirements. Rescheduling cannabis would not reduce the stringency of such requirements; conversely, approval of Sativex® will have no effect on the scheduling of crude herbal cannabis, which would remain in Schedule I. GW will naturally keep patients and physicians apprised as we achieve various milestones in the FDA regulatory process." 

[ Post Comment ]



 


Comment #3 posted by FoM on January 03, 2006 at 20:52:00 PT

Oh My 12 Miners Are Alive
That makes me cry. Miracles do happen.
[ Post Comment ]



 


Comment #2 posted by FoM on January 03, 2006 at 20:41:14 PT

A Big Question
How would a cancer patient apply to be in the study? I really want to know since my sister in laws husband has cancer of the vocal cord and could benefit from the cannabis spray rather then any smoke.
[ Post Comment ]



 


Comment #1 posted by FoM on January 03, 2006 at 20:25:57 PT

Cannabis Has Medicinal Benefits
It's time to change the laws and allow people to use the natural herb and it will allow the pharmaceutical companies to develop Cannabis into a good medicine for those too sick to even vaporize Cannabis. It can't stay Schedule I now!
[ Post Comment ]






  Post Comment