For the first time, a drug based on cannabis has been approved by the U.S. Food and Drug Administration. It's called Epidiolex, a medical formulation of cannabidiol (CBD), and it's also a first in the field of epilepsy treatments, as well.
Despite being derived from marijuana, the cannabinoid does not induce the well-known high that has made marijuana popular for recreational use, as GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex, assured the public in a statement they put out on Monday, June 25.
"This is an important medical advance," FDA Commissioner Dr. Scott Gottlieb also pointed out, adding that doctors who would like to prescribed Epidiolex to their patients can be confident that the new drug is uniformly effective as backed by "adequate and well-controlled clinical studies" leading to its approval.
Epidiolex was approved for the treatment of patients suffering from two kinds of epileptic symptoms. The first one, Dravet syndrome, is a form of life-long epilepsy, usually caused by a gene mutation, which expresses itself in the brain in children as young as 1. The second is the Lennox-Gastaut syndrome, a rare epilepsy syndrome that shows up in the form of seizures during early childhood.
The drug was approved for patients two years old and older. Unlike its more well-known cannabinoid colleague, tetrahydrocannabinol, or THC, this form of Cannabidiol it does not produce a high at all.
"Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds," Gottlieb added in his statement, encouraging medical researchers to consider the plant and its component on its own merits using properly controlled clinical trials.
Known side effects of the new drug may not include the high associated with marijuana, but it's been known to cause sleepiness, and its side effects may become more pronounced when Epidiolex is taken with other medications, according to Justin Gover, chief executive officer of GW Pharmaceuticals.