Raw Cannabis Extract Seeks FDA Approval Despite Scheduling Status

The company behind Sativex, the raw cannabis extract oral spray, GW Pharma have decided to push for approval by the U.S. Food and Drug Administration. The difference between Marinol, the “marijuana” pill that has been available in the US for a quarter century, and Sativex is the fact that Sativex is literally produced from from the cannabis plant and Marinol is a synthetic blend to create  Delta-9-tetrahydrocannabinol. Sativex is already available in five European countries and Canada.

GW Pharma produces all of the cannabis used in producing Sativex at this secret cultivation center in the south of England.  In their FAQ section GW claims the main goal of this facility, ” is the cultivation of highly consistent plants with defined cannabinoid ratios. Total yield of one or other cannabinoid is relatively less important than consistency.” They also pick phenotypes based on pest resistance and hybrid vigor.

Its not all peaches and cream though, Kris Hermes from Americans For Safe Access did have some concerns in the AP piece. He noted on companies rush to find a niche,

“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… 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,”

One other aspect of this I wondered about was the fact that raw cannabis is a Schedule One Narcotic, meaning according to the Feds it has no medical value. So HailMaryJane.com got in touch with Kris Hermes and asked if all raw cannabis, ie buds, would have to be moved to schedule two for Sativex to hit the shelves, Kris was kind enough to get back to us and said,

“Let’s just say that Sativex couldn’t be sold to patients in the U.S. without some change in federal policy. The feds could reschedule naturally extracted cannabis, but that dances dangerously close to admitting that the “whole cannabis plant” inherently has medical value. What is more likely is that the federal government will tie itself into a pretzel by making an exception for Sativex, like it did for Marinol (which is Schedule III). One things is for sure, it will create quite a controversy.”

So pretty much Sativex is either going to change the game for all medical cannabis, or just be another cheat from a pharmaceutical industry trying to make as much cash possible off medicine you can grow in your closet.

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Author: Jimi D

I'm a West Coast Bostonian transplant, California medical cannabis professional, safe access sympathizer, and I like letting folks know the news. Follow me on Twitter for breaking news @JimiDevine.

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