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U.S. health regulators on Monday approved the first prescription drug made from special cannabis plants bred to have a high content of a therapeutic chemical called CBD. This landmark approval of a product derived from marijuana could promote more research into a drug that remains illegal under Federal law. Interestingly, American public opinion polls indicate a growing acceptance of legalization for recreational and medical use. In recent years several states have approved voting referendums legalizing these uses at the state level.
The Food and Drug Administration (FDA) recently approved a medication, called Epidiolex, to treat two rare forms of epilepsy that begin in childhood. But it’s not quite medical marijuana due to only using a form of a chemical ingredient found in the cannabis plant — but not the one that gets users high. It’s not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.
British drugmaker GW Pharmaceuticals offers it in a fruit flavored syrup. They studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long blocked research into cannabis. FDA officials determined the drug reduced seizures when combined with older epilepsy drugs such as Keppra or Ethosuximide.
“It represents a new chapter, a landmark for therapy in the U.S. for epilepsy,” Dr. Orrin Devinsky, of NYU Langone Health’s Comprehensive Epilepsy Center, told CBS News. “Many of these children and young adults had significant reductions in their most severe seizures.One patient went from over twenty seizures a day to one or none some days.”
The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with AIDS/HIV. FDA Commissioner Scott Gottlieb suggested the agency would be scrutinizing CBD products with “uncertain dosages and formulations.” Mr. Gottlieb added, “We are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” Most makers of CBD oils, vapors, and edibles sidestep the issue by making only broad claims about general health and well-being.
A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. Wall Street analysts have previously predicted it could cost $25,000 per year, with annual sales eventually reaching $1 billion.
The laws related to medical or recreational use of cannabis have become more complicated in recent years. Nine states and the District of Columbia have legalized marijuana for recreational use. Another 20 states allow medical marijuana for a limited group of medical conditions, but the U.S. government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.
Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. Last year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.
GW Pharmaceuticals makes the drug in the U.K. from cannabis plants that are specially bred to contain high levels of CBD. And the company plans to continue importing the medicine, bypassing a confusing maze of U.S. regulations on the manufacture and distribution of substances restricted by the Drug Enforcement Agency (DEA).
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