For the first time, the FDA has announced that it will be approving a cannabis-based drug for use in the US. The drug, Epidiolex, will be approved for the treatment of two types of epilepsy: Dravet syndrome, which is a rare genetic illness that usually begins in young children, and Lennox-Gastaut syndrome, which also begins in childhood and causes seizures.
Epidiolex has been described by its manufacturer GW Pharmaceuticals as “first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.” CBD is one of over 80 active compounds found in cannabis; however, unlike other compounds like THC, it isn’t psychoactive and doesn’t produce a “high”.
Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval as “a historic milestone.” He added that the drug offers families “the first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies. 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.”
The FDA has previously approved some types of cannabinoids, which are legal in a number of US states, and can be used for other purposes like cancer pain relief and to treat the symptoms of mental health conditions like PTSD and anxiety. Epidiolex is due to become available to patients later in the year, although the costs are yet to be disclosed.
Based on recommendations from an advisory committee earlier in the year, doctors will be able to prescribe the drug for patients over the age of two. FDA Commissioner Dr. Scott Gottlieb said in a statement: “This is an important medical advance. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery.”