First Real Marijuana Drug Sativex Awaiting FDA OK
Posted by Marijuana Doctors on 01/24/2012 in Medical Marijuana News
It has been 25 years since the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, but according to drug companies, small biotech firms and university scientists, there are additional medicines which could soon be making their way onto the local shelves in your nearest pharmacy.
GW Pharma, is a British company, currently in the process of advanced clinical trials for the world’s first pharmaceutical, developed from actual raw marijuana, not its synthetic counterpart. Created as a treatment for patients suffering from cancer, the mouth spray, known as Sativex, has high hopes of receiving FDA approval by the end of 2013. Upon receiving approval, GW Pharma plans to proceed with marketing the spray, Sativex, in the U.S. Currently 16 states and the District of Columbia allow residents to legally use medical marijuana with the recommendation of their physician.
While possession of marijuana is currently still illegal in the United Kingdom, GW Pharma founder, Dr. Geoffrey Guy, received permission to grow the plant, almost 10 years ago, on the condition of developing a prescription drug. Company spokesman, Mark Rogerson, said that Dr. Guy originally proposed the idea at a scientific conference, which had been informative with evidence to support the argument that marijuana does indeed provide relief to patients suffering from multiple sclerosis. The British government welcomed the opportunity as a way to potentially “draw a clear line between recreational and medicinal use,” said Rogerson. Now GW Pharma is not only exploring advanced applications for Sativex, but they have also already begun developing other drugs with differing cannabis formulations.
Virginia Commonwealth University pharmacology professor and president of the International Cannabinoid Research Society, Aaron Lichtman, said, “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. 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 consists of marijuana’s two most commonly known elements, delta 9-THC and cannabidiol; and has already been approved in Canada, New Zealand and 8 other countries throughout Europe for the usage and treatment of muscle spasms related to multiple sclerosis.
Approval from the FDA would represent not only a victory for GW Pharmaceuticals, and Sativex, but also a monumental milestone within the marijuana movement. The U.S. Drug Enforcement Administration classifies marijuana as having no medicinal benefit or value and categorizes it as being a dangerous drug, however, the sudden availability of a chemically similar prescription drug would mean the federal government would be pressurized by people and industry alike to re-look its current position and policy on pot. Essentially it would pave the way ahead for other pharmaceutical companies to begin development and testing of cannabis based drugs.