Pubdate: Mon, 23 Jan 2012
Source: Commercial Appeal (Memphis, TN)
Copyright: 2012 Associated Press
Author: Lisa Leff, Associated Press


British Will Seek FDA OK for Pain Spray

SAN FRANCISCO (AP) - A quartercentury 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.

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. And it hopes to see FDA approval by 
the end of 2013.

Sativex contains marijuana's two best known components - delta 9THC 
and cannabidiol - 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 that stage."

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."
- ---
MAP posted-by: Jay Bergstrom