Pot-Based Drug Poised for FDA OK

Sativex for cancer pain already in advanced clinical trials
By Mary Papenfuss,  Newser User
Posted Jan 23, 2012 1:18 AM CST
Updated Jan 23, 2012 4:14 AM CST
Officials at GW Pharmaceuticals are hoping to get FDA approval for Sativex, a mouth spary they hope to market to treat cancer pain. The drug is already in advanced clinical trials.   (AP Photo/ GW Pharmaceuticals)

(Newser) – A company developing a marijuana-based mouth spray for cancer pain is hoping for FDA approval by next year. British firm GW Pharma is already carrying out advanced clinical trials for Sativex, the first pharmaceutical developed from raw marijuana, reports AP. Sativex contains marijuana components delta 9-THC and cannabidiol, and has already been approved in eight European nations and Canada and New Zealand for easing muscle spasms linked to multiple sclerosis. FDA approval would be a major breakthrough in the stalemate between federal drug enforcement and the 16 states where medical marijuana is legal.

"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 a pharmacology professor and president of the International Cannabinoid Research Society. GW Pharma received permission to grow marijuana in Great Britain—where marijuana possession is illegal—a decade ago, expressly to develop a prescription drug. The firm, and US companies, are exploring new formulations linked to marijuana. In 1985 the FDA approved capsules containing synthetic—rather than raw—elements of marijuana for treatment of chemotherapy side-effects, and, later, to stimulate the appetite of AIDS sufferers. That drug's patent expired last year. (Read more GW Pharma stories.)

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