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News (Media Awareness Project) - US: Marijuana-Based Prescription Drug Seeks OK From FDA
Title:US: Marijuana-Based Prescription Drug Seeks OK From FDA
Published On:2012-01-29
Source:Austin American-Statesman (TX)
Fetched On:2012-01-30 06:02:49
MARIJUANA-BASED PRESCRIPTION DRUG SEEKS OK FROM FDA

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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