A British company is hoping to draw a line between the U.S. Drug Enforcement Administration and the Food and Drug Administration as it awaits a regulatory decision on the world’s first pharmaceutical developed from raw marijuana.
Sixteen states in the U.S. allow residents to use marijuana legally for medicinal purposes, but the DEA still considers the plant a dangerous drug with no medical value.
GW Pharma is wondering which side the FDA will take as the company awaits a regulatory decision on Sativex, its mouth spray containing marijuana’s two primary components, for the treatment of cancer pain.
The company hopes to receive FDA approval by the end of 2013.
"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," Aron Lichtman, a Virginia Commonwealth University pharmacology professor and president of the International Cannabinoid Research Society, told the Associated Press. "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.'"
Sativex has already been approved in Canada, New Zealand and eight European countries for relieving muscle spasms associated with multiple sclerosis.