Pubdate: Sun, 29 Jan 2012
Source: Austin American-Statesman (TX)
Copyright: 2012 Associated Press
Author: Lisa Leff, Associated Press


SAN FRANCISCO (AP) - A quarter-century after the U.S. Food and Drug 
Administration approved the first prescription drugs based on the 
main psychoactive ingredient in marijuana, additional medicines 
derived from or inspired by the cannabis plant could soon be making 
their way to pharmacy shelves, according to drug companies, small 
biotech firms and university scientists.

A British company, GW Pharma, is in advanced clinical trials for the 
world's first pharmaceutical developed from raw marijuana instead of 
synthetic equivalents- a mouth spray called Sativex it seeks to 
market in the U.S. as a treatment for cancer pain. It hopes to see 
FDA approval by the end of 2013.

Sativex contains marijuana's two best-known components - delta 9-THC 
and cannabidiol - and has been approved in Canada, New Zealand and 
eight European countries for a different usage, relieving muscle 
spasms associated with multiple sclerosis.

FDA approval would represent an important milestone in the nation's 
often uneasy relationship with marijuana, which 16 states and the 
District of Columbia already allow residents to use legally with 
doctors' recommendations. The U.S. Drug Enforcement Administration 
categorizes pot as a dangerous drug with no medical value, but the 
availability of a chemically similar prescription drug could increase 
pressure on the federal government to revisit its position and 
encourage other drug companies to follow in GW Pharma's footsteps.

"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 Aron Lichtman, a Virginia Commonwealth University 
pharmacology professor and president of the International Cannabinoid 
Research Society. "It seems to me a company with a great deal of 
vision would say, 'If there is this demand and need, we could develop 
a drug that will help people and we will make a lot of money.'"

In 1985, the FDA approved two drug capsules containing synthetic THC, 
Marinol and Cesamet, to ease side-effects of chemotherapy in cancer 
patients. The agency eventually allowed Marinol to be prescribed to 
stimulate the appetites of AIDS patients.

Doctors and multiple sclerosis patients are cautiously optimistic 
about Sativex. The National Multiple Sclerosis Society has not 
endorsed marijuana use by patients, but the organization is 
sponsoring a study by a University of California, Davis neurologist 
to determine how smoking marijuana compares with Marinol in 
addressing painful muscle spasms.

"The cannabinoids and marijuana will, eventually, likely be part of 
the clinician's armamentarium, if they are shown to be clinically 
beneficial," said Timothy Coetzee, the society's chief research 
officer. "The big unknown in my mind is whether they are clearly beneficial."
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