Pot-based prescription drug looks for FDA OK
By LISA LEFF, Associated Press â•„ 1 hour agohttp://www.google.com/hostednews/ap/art ... 5232e2cf62
SAN FRANCISCO (AP) â•‰ 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
A British company, GW Pharma, is in advanced clinical trials for the
world's first pharmaceutical developed from raw marijuana instead of
synthetic equivalentsâ•‰ a mouth spray it hopes to market in the U.S. as a
treatment for cancer pain. And it hopes to see FDA approval by the end of
Sativex contains marijuana's two best known components â•‰ delta 9-THC and
cannabidiol â•‰ and already 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.'"
Possessing marijuana still is illegal in the United Kingdom, but about a
decade ago GW Pharma's founder, Dr. Geoffrey Guy, received 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 multiple sclerosis 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.
"We were the first ones to charge forward and a lot of people were watching
to see what happened to us," Rogerson said. "I think we are clearly past
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 dissolving pills, creams and skin patches and
perhaps be used for other ailments.
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 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."
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, according to Lichtman.
"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.
But scientists and drug companies that are exploring pot's promise predict
the path will ultimately be successful, if long and littered with setbacks.
One is Alexandros Makriyannis, director of the Center for Drug Discovery at
Northeastern University and founder of a small Boston company that hopes to
market synthetic pain products that are chemically unrelated to marijuana,
but work similarly on the body or inhibit the cannabinoid receptors. He
also has been working on a compound that functions like the failed Acomplia
but without the depressive effects.
"I think within five to 10 years, we should get something," Makriyannis
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