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Old 05-15-2014, 01:57 AM #51
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Default Sativex

This investigational drug has been given "Fast Track" status by the FDA, which might make it available in the US by the end of 2014:

http://www.marketwatch.com/story/gw-...ain-2014-04-28
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Old 05-15-2014, 02:59 AM #52
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Default CBD Hemp Oil

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Originally Posted by nilram View Post
It's so awesome that you've provided this info, beatle! I tried cannabis several years ago and found it made me groggy, dizzy and didn't help my pain -- at the time, though, it was hard to get good information about high-CDB strains. Much easier to find a high-CDB strain now.

HOWEVER, after looking around, I've found that anyone in the US can get CDB derived from hemp. As you've said, CDB is not psychoactive. It also happens to be present in abundance in hemp. Although we can't grow hemp in the US, anyone here can buy hemp products, including hemp oil.

Here are some links I've found that will be of interest to those interested in CDB. My own path right now is to find a hemp-based product rather than spending the $200+ it takes for a medical marijuana card in my state.

http://www.projectcbd.org/

http://www.leafly.com/news/medical/h...-access-no-pro
I live in northern Virginia, just across the river from DC and Maryland where I could get medical marijuana legally if I lived in either jurisdiction, but it would be a huge change to move at this point in life, so I'm very interested in the CBD hemp oil option. I found a provider based in Colorado that ships to all 50 states and have placed an order. It ain't cheap, but it's worth a try.

http://www.bluebird-botanicals.com/CBD_Oil_FAQ.html
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Old 05-15-2014, 06:51 AM #53
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Please keep us posted on your results.
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Old 05-15-2014, 01:02 PM #54
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Quote:
Originally Posted by nsw43 View Post
This investigational drug has been given "Fast Track" status by the FDA, which might make it available in the US by the end of 2014:
Investigational? This is long overdue considering it's been in use in 25 other countries (including Canada) for years. In the US, Sativex has been stalled in the limbo known Phase III trials for longer than most medications—IMO for political rather than medical/science reasons.

I don't want to be "Captain Bringdown", but let's not get too excited... yet; according to the article, initial data from the Phase III trials is expected around the end of this year. I don't know the average lag between that and actual availability for prescription/use—if they decide the data passes muster. MrsD/anyone? There may still be other obstacles.

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Old 05-15-2014, 01:07 PM #55
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Lightbulb

Since the drug already has a dosage form, and is in production already...the lag time may be shorter. (and studies are available)

However Savella took many years to clear the FDA, even though it was already in use in Mexico and other countries.

So who knows? With the liberalization of MJ in many states, it may go thru in a year or two here. But it could be 5 yrs easily too.
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Old 05-15-2014, 01:54 PM #56
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Default A couple of condisderations ^^

- Sativex is an expensive manufactured chemical compound. Unlike cannabis, it is not natural if that matters to anyone. It is legally available in 10 or 11 counties however it will be some time before it is prescribed for neuropathic pain in the US and even more time before it will be covered by insurance.

- By contrast, most CBD/THC products sold in states where MMJ is legal are 100% natural and far less expensive.

- In some states where MMJ is legal, a number of plants are permitted in the home. In other words, patients are purchasing grow kits and specific strain seeds and growing their own medicine.

- Many MMJ patients are also vaporizing rather than smoking their MMJ for relief from several neuropathic conditions, cancer, AIDS, epilepsy, fibromyalgia, MS, …the list is endless. Vaporizing merely introduces heat to the cannabis product and the user inhales the vapor rather than smoke. This is just one of several ways to use cannabis for chronic pain.
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Old 05-15-2014, 02:27 PM #57
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Quote:
Originally Posted by beatle View Post
- Sativex is an expensive manufactured chemical compound. Unlike cannabis, it is not natural if that matters to anyone.
I'm not sure where you got that information.
Quote:
[Sativex] is distinct from all other pharmaceutically produced cannabinoids currently available because it is a mixture of compounds derived from Cannabis plants, rather than a mono-molecular synthetic product. The drug is a pharmaceutical product standardised in composition, formulation, and dose, although it is still effectively a tincture of the cannabis plant.
http://en.wikipedia.org/wiki/Nabiximols
Quote:
Below are a few facts about Sativex that should be considered:

1. Sativex is a marijuana extract.

Despite its pharmaceutical sounding name, Sativex is made from the cannabis plant itself. GW Pharmaceuticals CEO Geoffrey Guy has noted to the press that Sativex contains all of the same compounds found in cannabis.
http://www.leafscience.com/2014/03/0...-know-sativex/
One of the most difficult arguments to overcome against legalization and to sway the medical community has to do with dose standardization/purity issues, which Sativex ostensibly overcomes. It contains the 2 desired active ingredients in controllable measured amounts, while whole plant MMJ contains literally hundreds of substances in varying amounts—even within the same strain and/or clones of the same plant (due to growth variables).

I'm not arguing for/against here—just trying to explain what I see as differences & obstacles.

Your other points seem spot-on.

Doc
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Old 05-15-2014, 03:46 PM #58
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Quote:
Originally Posted by Dr. Smith View Post

[Sativex] is distinct from all other pharmaceutically produced cannabinoids currently available because it is a mixture of compounds derived from Cannabis plants...
Keywords: "derived from"...

And the "mixture of compounds" is just THC and CBD, the same as literally hundreds of MMJ products, many of which are now being grown organically under strict, controlled conditions and offered without the following additives of Sativex:

Extraction solvent: Liquid carbon dioxide
Excipients: Ethanol anhydrous, Propylene glycol

Currently, Sativa would cost patients about $14,000 for an annual prescription give or take and we should expect insurance companies to fight tooth and nail to avoid covering it with the exception of terminal cancer or MS while many of us would wait around, literally suffering in pain either from our neurological deficits or from side-effects of many of the barbaric pharmaceuticals prescribed to us.

I presume this will all change over time as more data comes out in support of cannabis-based medicines and more products are brought to market.
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Old 05-15-2014, 04:26 PM #59
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Quote:
Originally Posted by Dr. Smith View Post
Investigational? This is long overdue considering it's been in use in 25 other countries (including Canada) for years. In the US, Sativex has been stalled in the limbo known Phase III trials for longer than most medications—IMO for political rather than medical/science reasons.

I don't want to be "Captain Bringdown", but let's not get too excited... yet; according to the article, initial data from the Phase III trials is expected around the end of this year. I don't know the average lag between that and actual availability for prescription/use—if they decide the data passes muster. MrsD/anyone? There may still be other obstacles.

Doc
You are so right about how long Sativex has been in limbo. I think they got permission to start Phase III trials in 2007 and yet, according to this story, they only recruited participants in 2013. I do believe "Fast Track" will accelerate approval; it's just a question of by how much.
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Old 05-15-2014, 04:30 PM #60
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Quote:
Originally Posted by beatle View Post
Keywords: "derived from"...

And the "mixture of compounds" is just THC and CBD, the same as literally hundreds of MMJ products, many of which are now being grown organically under strict, controlled conditions and offered without the following additives of Sativex:

Extraction solvent: Liquid carbon dioxide
Excipients: Ethanol anhydrous, Propylene glycol

Currently, Sativa would cost patients about $14,000 for an annual prescription give or take and we should expect insurance companies to fight tooth and nail to avoid covering it with the exception of terminal cancer or MS while many of us would wait around, literally suffering in pain either from our neurological deficits or from side-effects of many of the barbaric pharmaceuticals prescribed to us.

I presume this will all change over time as more data comes out in support of cannabis-based medicines and more products are brought to market.
All good points. However, not everyone lives in a state where MMJ products are legal. If it gets approved, Sativex could be a godsend to some who don't have access to the wonderful products available in Colorado and other states.
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