MARIJUANA-BASED PRESCRIPTION DRUG LOOKS TOWARD FDA'S APPROVAL

U.K.-Based Gw Pharma Is in Advanced Clinical Trials for the World's
First Pharmaceutical Developed From Raw Marijuana - a Mouth Spray It
Hopes to Market in the U.S. As a Treatment for Cancer Pain.

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 itself 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 it hopes 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 already has been approved in Canada, New
Zealand and eight European countries for 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, including
Washington, 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,' " Lichtman said.

Possessing marijuana still is illegal in the U.K., but about a decade
ago GW Pharma's founder, Dr. Geoffrey Guy, won permission to grow it
to develop a prescription drug. Guy proposed the idea at a scientific
conference that heard anecdotal evidence that pot provides relief to
MS patients, and the British government welcomed it as a potential
way "to draw a clear line between recreational and medicinal use,"
company spokesman Mark Rogerson said.

In addition to exploring new applications for Sativex, the company is
developing drugs with different cannabis formulations.

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. The drug's patent expired
last year, and other U.S. companies have been developing formulations
that could be administered through pills, creams and skin patches,
and perhaps be used for other ailments.

Doctors and MS patients are cautiously optimistic about Sativex. The
National Multiple Sclerosis Society has not endorsed marijuana use by
patients, but it is sponsoring a study by a University of California,
Davis neurologist to determine how smoking marijuana compares to
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."

Opponents and supporters of crude marijuana's effectiveness generally
agree that more research is needed. And marijuana advocates fear that
the government will use any new prescription products to justify a
continued prohibition on marijuana use. .

"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," Americans for Safe Access spokesman Kris Hermes said.

"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," Hermes said.

Interest in new and better marijuana-based medicines has been
building since the discovery in the late 1980s and 1990s that mammals
have receptors in their central nervous systems, several organs and
immune systems for the chemicals in botanical cannabis and that their
bodies also produce natural cannabinoids that work on the same receptors.

One of the first drugs to build on those breakthroughs was an
anti-obesity medication that blocked the same chemical receptors that
trigger the munchies in pot smokers. Under the name Acomplia, it was
approved throughout Europe and heralded as a possible new treatment
for smoking cessation and metabolic disorders that can lead to heart attacks.

The FDA was reviewing its safety as a diet drug when follow-up
studies showed that people taking the drug were at heightened risk of
suicide and other psychiatric disorders. French manufacturer
Sanofi-Aventis, pulled it from the market in late 2008.

Given that drug companies already were reluctant "to touch anything
that is THC-like with a 10-foot- pole," the setback had a chilling
effect on cannabinoid drug development, Lichtman said.

"Big companies like Merck and Pfizer were developing their own
versions (of Acomplia), so all of those programs they spent millions
and millions on just went away ... " he said.