Cannabis Medicines Wait For FDA Approval - Cannabis Law and Politics - International Cannagraphic Magazine Forums

RetroGrow · 01-23-2012, 07:28 PM

New medicines based on cannabis are waiting for FDA approval, a quarter century after Marinol was first approved. GW Pharma is in advanced clinical trials on "Sativex", which is already approved in a number of countries for other uses. GW Pharma is targeting multiple sclerosis.
From the article:
"SAN FRANCISCO (AP) - A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists.

A British company, GW Pharma, is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents_ a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013.

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

FDA approval would represent an important milestone in the nation's often uneasy relationship with marijuana, which 16 states and the District of Columbia already allow residents to use legally with doctors' recommendations. The U.S. Drug Enforcement Administration categorizes pot as a dangerous drug with no medical value, but the availability of a chemically similar prescription drug could increase pressure on the federal government to revisit its position and encourage other drug companies to follow in GW Pharma's footsteps.

"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 marijuana still is illegal in the United Kingdom, 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.

In addition to exploring new applications for Sativex, the company is developing drugs with different cannabis formulations.

"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 drug capsules 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 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 marijuana compares to Marinol in addressing painful muscle spasms.

"The cannabinoids and marijuana will, eventually, likely be part of the clinician's armamentarium, if they are shown to be clinically beneficial," said Timothy Coetzee, the society's chief research officer. "The big unknown in my mind is whether they are clearly beneficial."

Opponents and supporters of crude marijuana's effectiveness generally agree that more research is needed. And marijuana advocates fear that the government will use any new prescription products to justify a continued prohibition on marijuana use. .

"To the extent that companies can produce effective medication that utilizes the components of the plant, that's great. But that should not be the exclusive access for people who want to be able to use medical marijuana," Americans for Safe Access spokesman Kris Hermes said. "That's the race against time, in terms of how quickly can we put pressure on the federal government to recognize the plant has medical use versus the government coming out with the magic bullet pharmaceutical pill."

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 that blocked the same chemical receptors that trigger the munchies in pot smokers. Under the name Acomplia, it 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. French manufacturer Sanofi-Aventis, 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.

"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..." he said.

But scientists and drug companies that are exploring pot's promise predict the path will ultimately be successful, if long and littered with setbacks.

One is Alexandros Makriyannis, director of the Center for Drug Discovery at Northeastern University and founder of a small Boston company that hopes to market synthetic pain products that are chemically unrelated to marijuana, but work similarly on the body or inhibit the cannabinoid receptors. He also has been working on a compound that functions like the failed Acomplia but without the depressive effects.

"I think within five to 10 years, we should get something," Makriyannis said.

https://www.breitbart.com/article.php...show_article=1

Fuzz420 · 01-28-2012, 08:26 PM

(NaturalNews) The pressure is on for researchers and pharmaceutical companies to develop drug-based, non-synthetic versions of marijuana for medical use, as the US Food and Drug Administration (FDA) is poised to approve such varieties in the near future. But this potential approval appears to be reserved only for Big Pharma, as the marijuana plant itself could continue to remain a controlled substance at the federal level with no recognized health benefits.

The Associated Press (AP) reports that GW Pharma, a British pharmaceutical company, is currently undergoing advanced clinical trials for the world's first drug made from raw marijuana, which it will seek FDA approval for by the end of 2013. There are currently a number of synthetic cannabinoid drugs on the market that have been approved by the FDA, but none that incorporate actual marijuana (https://www.justice.gov/dea/ongoing/marinol.html).

Learn more: https://www.naturalnews.com/034796_ma...#ixzz1kmag53AN

Known as Sativex, the marijuana spray contains both delta 9-tetrahydrocannabinol (THC) and cannabidiol, which are considered to be raw marijuana's two most well-known active components. GW Pharma is hoping to receive US FDA approval of Sativex for the treatment of cancer pain, as the drug has already been approved in several other countries for the treatment of muscle spasm pain caused by multiple sclerosis.

While this is great news on the medical marijuana front in America, it does not necessarily imply that either the FDA or the US Drug Enforcement Agency (DEA) will loosen its regulatory grip on the actual marijuana plant. Like regulators did with the stevia plant, marijuana could receive approval only in patented form from drug companies (https://www.healthynewage.com/blog/stevia-fda-approved/).

"To the extent that companies can produce effective medication that utilizes the components of [marijuana], that's great. But that should not be the exclusive access for people who want to be able to use medical marijuana," said Kris Hermes, a spokesman from the pro-marijuana group Americans for Safe Access.

"That's the race against time, in terms of how quickly can we put pressure on the federal government to recognize the plant has medical use versus the government coming out with the magic bullet pharmaceutical pill."

If the federal government does approve Sativex and other drug-based forms of real marijuana, though, it will have to change its official position that marijuana has no medical benefits. If the plant's two most known ingredients are approved for medical use as a drug, in other words, the government's only choice to remain consistent will be to finally admit that marijuana does have medicinal value, and thus legalize it.

Sources for this article include:

https://www.breitbart.com/article.php...show_article=1

Learn more: https://www.naturalnews.com/034796_ma...#ixzz1kmalpiK7

OLDproLg · 02-05-2012, 06:52 PM

Well,its a baby steep!

Try they will to control it,but the plants diversity will win over all..
How dumb are they to drag this out,lets see now......
Way back when they found its medical use in the 60's for glocoma then appitite stimulant..
Now with all the strain breeding an researching we have found many strains of medical values!!!!!
WHAT A COUNTRY THAT TALKS WITH A FORKED TONGUE<

An the war goes on....

oldbluedog · 02-15-2012, 07:12 PM

Reload

LOL Once the big pharma is in they will control it all.

dsski64 · 02-21-2012, 02:10 PM

They will just wait kill more of us veterans with their useless painkillers and other bad meds

TB Gardens · 02-21-2012, 02:19 PM

GW Pharma is the company that started patenting the plant, no? And not even like the whole plant, they patented specific traits & strains..... Word bro.

01-23-2012, 07:28 PM	#1
RetroGrow Senior Member Join Date: Mar 2008 Posts: 7,613	Cannabis Medicines Wait For FDA Approval New medicines based on cannabis are waiting for FDA approval, a quarter century after Marinol was first approved. GW Pharma is in advanced clinical trials on "Sativex", which is already approved in a number of countries for other uses. GW Pharma is targeting multiple sclerosis. From the article: "SAN FRANCISCO (AP) - A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists. A British company, GW Pharma, is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents_ a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013. Sativex contains marijuana's two best known components—delta 9-THC and cannabidiol—and already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis. FDA approval would represent an important milestone in the nation's often uneasy relationship with marijuana, which 16 states and the District of Columbia already allow residents to use legally with doctors' recommendations. The U.S. Drug Enforcement Administration categorizes pot as a dangerous drug with no medical value, but the availability of a chemically similar prescription drug could increase pressure on the federal government to revisit its position and encourage other drug companies to follow in GW Pharma's footsteps. "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 marijuana still is illegal in the United Kingdom, 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. In addition to exploring new applications for Sativex, the company is developing drugs with different cannabis formulations. "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 drug capsules 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 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 marijuana compares to Marinol in addressing painful muscle spasms. "The cannabinoids and marijuana will, eventually, likely be part of the clinician's armamentarium, if they are shown to be clinically beneficial," said Timothy Coetzee, the society's chief research officer. "The big unknown in my mind is whether they are clearly beneficial." Opponents and supporters of crude marijuana's effectiveness generally agree that more research is needed. And marijuana advocates fear that the government will use any new prescription products to justify a continued prohibition on marijuana use. . "To the extent that companies can produce effective medication that utilizes the components of the plant, that's great. But that should not be the exclusive access for people who want to be able to use medical marijuana," Americans for Safe Access spokesman Kris Hermes said. "That's the race against time, in terms of how quickly can we put pressure on the federal government to recognize the plant has medical use versus the government coming out with the magic bullet pharmaceutical pill." 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 that blocked the same chemical receptors that trigger the munchies in pot smokers. Under the name Acomplia, it 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. French manufacturer Sanofi-Aventis, 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. "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..." he said. But scientists and drug companies that are exploring pot's promise predict the path will ultimately be successful, if long and littered with setbacks. One is Alexandros Makriyannis, director of the Center for Drug Discovery at Northeastern University and founder of a small Boston company that hopes to market synthetic pain products that are chemically unrelated to marijuana, but work similarly on the body or inhibit the cannabinoid receptors. He also has been working on a compound that functions like the failed Acomplia but without the depressive effects. "I think within five to 10 years, we should get something," Makriyannis said. https://www.breitbart.com/article.php...show_article=1
	Quote

01-28-2012, 08:26 PM	#2
Fuzz420 Ganja Smoker Extraordinaire Join Date: May 2008 Location: Infinte Consciousness of One Posts: 2,354	FDA may legalize pot medicine, but only for Big Pharma (NaturalNews) The pressure is on for researchers and pharmaceutical companies to develop drug-based, non-synthetic versions of marijuana for medical use, as the US Food and Drug Administration (FDA) is poised to approve such varieties in the near future. But this potential approval appears to be reserved only for Big Pharma, as the marijuana plant itself could continue to remain a controlled substance at the federal level with no recognized health benefits. The Associated Press (AP) reports that GW Pharma, a British pharmaceutical company, is currently undergoing advanced clinical trials for the world's first drug made from raw marijuana, which it will seek FDA approval for by the end of 2013. There are currently a number of synthetic cannabinoid drugs on the market that have been approved by the FDA, but none that incorporate actual marijuana (https://www.justice.gov/dea/ongoing/marinol.html). Learn more: https://www.naturalnews.com/034796_ma...#ixzz1kmag53AN Known as Sativex, the marijuana spray contains both delta 9-tetrahydrocannabinol (THC) and cannabidiol, which are considered to be raw marijuana's two most well-known active components. GW Pharma is hoping to receive US FDA approval of Sativex for the treatment of cancer pain, as the drug has already been approved in several other countries for the treatment of muscle spasm pain caused by multiple sclerosis. While this is great news on the medical marijuana front in America, it does not necessarily imply that either the FDA or the US Drug Enforcement Agency (DEA) will loosen its regulatory grip on the actual marijuana plant. Like regulators did with the stevia plant, marijuana could receive approval only in patented form from drug companies (https://www.healthynewage.com/blog/stevia-fda-approved/). "To the extent that companies can produce effective medication that utilizes the components of [marijuana], that's great. But that should not be the exclusive access for people who want to be able to use medical marijuana," said Kris Hermes, a spokesman from the pro-marijuana group Americans for Safe Access. "That's the race against time, in terms of how quickly can we put pressure on the federal government to recognize the plant has medical use versus the government coming out with the magic bullet pharmaceutical pill." If the federal government does approve Sativex and other drug-based forms of real marijuana, though, it will have to change its official position that marijuana has no medical benefits. If the plant's two most known ingredients are approved for medical use as a drug, in other words, the government's only choice to remain consistent will be to finally admit that marijuana does have medicinal value, and thus legalize it. Sources for this article include: https://www.breitbart.com/article.php...show_article=1 Learn more: https://www.naturalnews.com/034796_ma...#ixzz1kmalpiK7 __________________ Two Veg PC's and 250 HPS XXL Black & Decker Cab Kali Most, Jack Herer F6, F-13 F2, Chocolate Rain, Chem D, Green Manalishi, Romulan x Romulan Max and Northern Lights x Amnesia Haze Grow 250w+ HPS Operation Black & Decker XXL CAB(under construction)
	Quote

02-05-2012, 06:52 PM	#3
OLDproLg Banned Join Date: Jul 2011 Location: jungle in HELL Posts: 1,540	Well,its a baby steep! Try they will to control it,but the plants diversity will win over all.. How dumb are they to drag this out,lets see now...... Way back when they found its medical use in the 60's for glocoma then appitite stimulant.. Now with all the strain breeding an researching we have found many strains of medical values!!!!! WHAT A COUNTRY THAT TALKS WITH A FORKED TONGUE< An the war goes on....
	Quote

02-15-2012, 07:12 PM	#4
oldbluedog Member Join Date: Nov 2011 Location: Usually out in the garden. Posts: 31	Reload LOL Once the big pharma is in they will control it all.
	Quote

02-21-2012, 02:10 PM	#5
dsski64 New Member Join Date: Feb 2012 Posts: 3	They will just wait kill more of us veterans with their useless painkillers and other bad meds
	Quote

02-21-2012, 02:19 PM	#6
TB Gardens Your daddy says I'm no good, Your momma says keep away Join Date: May 2007 Location: mountains Posts: 1,248	GW Pharma is the company that started patenting the plant, no? And not even like the whole plant, they patented specific traits & strains..... Word bro.
	Quote