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Sativex clinical trials approved in the USA

 
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RogerChristie
Cannabis Sacrament Minister.
Cannabis Sacrament Minister.


Joined: 16 Feb 2004
Posts: 1062
Location: Hilo, Kingdom of Hawai'i

PostPosted: Mon Aug 28, 2006 11:18 pm    Post subject: Sativex clinical trials approved in the USA Reply with quote

Aloha.

Progress in the field of Cannabis medicines is to be applauded. GW Pharmaceuticals has done very well against all the odds and obstacles. As far as I know, their spray is similar to our tincture drops, only different.

Note: GW Pharmaceuticals doesn't want their medicine to give users any feelings of "euphoria" so they purposely compound and prescribe smaller amounts of Cannabis than most of us would take to feel good. Euphoria is a 'side-effect'? Linear thinkers can be so (un-)funny sometimes.

Euphoria for all!

Roger


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Firm helps get marijuana-based drug into trials

Sunday, August 27, 2006
By Michelle Miron

mmiron@kalamazoogazette.com 388-2733

A cannabis-derived painkiller will undergo Phase III clinical trials in the United States beginning later this year, partly because of help from Kalamazoo life-sciences consulting firm Apjohn Group LLC.

Apjohn, the firm started in 2003 by former Pharmacia Corp. executive Donald Parfet and others, was hired by GW in early 2005 to help bring the drug closer to U.S. clinical trials.

`Apjohn played an extremely important role in helping GW prepare the documentation for the Investigational New Drug Application,'' said Mark Rogerson, GW's press and public-relations representative. ``(That) led to a very successful result from the Food and Drug Administration -- the agency's allowing us to go directly into pivotal Phase III trials.''

The drug is the first commercial cannabis (marijuana) -derived drug in the world. It's used in Canada to treat patients with multiple sclerosis, and current trials are targeted at patients with advanced cancer whose pain has not been relieved by opioid medications like morphine, according to GW.

More than 2,000 patients and subjects have been involved in Sativex clinical trials in Europe and elsewhere, Rogerson said. The drug was also recently approved for limited use in Spain.

GW projects that an application to market Sativex in the U.S. could be submitted within 24 to 36 months after U.S. trials begin.

``The time scale after that is up to the FDA,'' Rogerson said.

GW was founded in 1998 and also focuses on cannabis-derived pharmaceuticals for patients with spinal-cord injuries, rheumatoid arthritis, neuropathic pain and other conditions. Its operations encompass botanical research, cultivation, extraction, formulation and medication delivery.


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