First FDA approved cannabis-based drug now available by prescription
The first cannabis-derived medication approved by the Food and Drug Administration is now available by prescription in every state, according to its manufacturer.
Epidiolex, manufactured by GW Pharmaceuticals, is intended to treat seizures associated with two rare and severe forms of epilepsy that begin in childhood. The drug is made of cannabidiol (CBD), a component of marijuana that doesn’t give users a high.
“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures,” Justin Gover, CEO of GW Pharmaceuticals, said in a statement.
“We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients,” Gover said.
The hope among CBD advocates is that the FDA’s approval could spur more research into medical marijuana products, though marijuana itself remains illegal.
Epidiolex was approved by the FDA in June, and the Drug Enforcement Administration (DEA) classified it as a Schedule V substance, the least restrictive schedule of a controlled substance. That cleared the way for GW to begin marketing its drug.
Medical marijuana is available in about half of U.S. states. But federal regulations still classify CBD as a Schedule 1 drug, which means it has no medical value and a high potential for abuse because it is a chemical component of the cannabis plant.