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Sativex lights up marijuana debate with FDA

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Sativex, a pot-based prescription drug spray derived not from a synthetic equivalent but from the cannabis plant itself, is jonesing for U.S. Food and Drug Administration approval more than 25 years after the first synthetic THC capsules were swallowed.

Should the medicinal mouth spray get the green light, the world's first pharmaceutical developed from raw marijuana, and similar medicines, could soon find their way to pharmacy shelves, say drug companies, biotech firms and university scientists.

GW Pharma in advanced clinical trials for the drug. The British company wants to push it to the U.S. market as a treatment for cancer pain, and is hoping for FDA approval by the end of 2013.

Containing marijuana's two best known components — delta 9-THC and cannabidiol — Sativex is already approved in Canada, New Zealand and eight European countries in relieving muscle spasms associated with multiple sclerosis.

The National Multiple Sclerosis Society has not endorsed marijuana use by patients, however, the organization is sponsoring a study at the University of California, Davis to determine if the practice is "clinically beneficial," and to see how it compares to synthetic THC in addressing painful muscle spasms.

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