The United States Food and Drug Administration (FDA) has approved a cannabis-based drug for the treatment of epilepsy in children as young as two years old. Manufactured by the United Kingdom’s GW Pharmaceuticals, Epidiolex will become the first cannabis-based drug on the American market.
Expected to become available this fall, the medicine uses a chemical extracted from the cannabis plant called cannabidiol (CBD). Unlike tetrahydrocannabinol (THC), the psychoactive substance found in the marijuana plant, cannabidiol does not produce a high.
The drug has been approved to treat Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two rare and severe forms of epilepsy. The conditions often begin during childhood and have high rates of early mortality. Many patients with LGS and Dravet syndrome require multiple seizure medications, with a majority being resistant to currently available treatments.
In a statement published on Monday, GW Pharmaceuticals CEO Justin Gover, called the approval “a historic milestone,” adding that the drug provides families with “the first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies.”
Although Epidiolex is the first cannabis-based medication to receive FDA approval, CNN reports that the agency has approved synthetic versions of some of the marijuana plant’s cannabinoid chemicals for the treatment of other conditions, such as cancer pain relief.
“These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care,” Gover added.
“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy,” explained Elizabeth Thiele, director of the pediatric epilepsy program at Massachusetts General Hospital and a lead investigator in the Epidiolex clinical programme. “These children and their families face a long and challenging road and very few achieve adequate seizure control.”
Thiele said that clinical trials show “this medication may help meet the need for this specific paediatric patient population and is now the first to be approved by the FDA in Dravet syndrome.”
The cost of the medicine has not been disclosed. According to CNN, Gover said that it would be announced at a later time after being discussed with insurance companies.
GW Pharmaceuticals told Sky News it hopes that Epidiolex’s FDA approval will pave the way for approval in Britain.
“This is a new breakthrough in the field of childhood-onset epilepsy. This treatment we have studied for the last five years,” Gover told Ian King Live last week.
“We believe it would a breakthrough in the US and hopefully in the UK next year,” he added.
Gover told CNN that the European Medical Society is currently considering approving Epidiolex. A decision is expected in the first quarter of next year.
Marijuana contains over 400 different compounds and 80 active cannabinoid chemicals. In a statement released on Monday, US Food and Drug Administration Commissioner Dr Scott Gottlieb stressed that although the drug “is an important medical advance… it’s also important to note that this is not an approval of marijuana or all of its components.”