For advocates of cannabis medicines, FDA support is a holy grail of sorts. And it was achieved in part yesterday when the FDA put their stamp of approval on a highly regulated, meticulously formulated cannabis pharmaceutical.
If this is news to you, you’re probably not the parent of a child with severe epilepsy—Lennox-Gastaut and Dravet syndrome—or you’d have been waiting for this response since April when an advisory committee unanimously recommended the drug for this use.
The drug is called Epidiolex, and GW Pharmaceuticals in Britain produce it. The oral solution containing highly purified cannabidiol, or CBD, which is one of many medicinal compounds in the cannabis plant. It includes such minimal amounts of THC that it does not induce euphoria.
The story of Epidiolex began with Sam Vogelstein, a Berkeley, California, youngster who once was having as many as 100 seizures a day. In late 2012, Sam became the first person from the US to take the drug. His seizures declined sharply, and the company soon began creating unapproved marijuana-derived medicines under the FDA’s “expanded access” program.
The drug is considered a valuable addition to the limited options for treating severe childhood-onset epilepsy. Not all patients respond to traditional medications, and it was a case of treatment-resistant epilepsy in Charlotte Figi that put the Stanley Brothers and their Charlotte’s Web CBD oil on the map.
Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in North America. The difference is that Epidiolex has undergone stringent FDA review for safety and effectiveness.
Alana seeks to see cannabis from the perspective of politicians, advocates, entrepreneurs, and consumers. She got her start with a byline in the arts and culture section and crossed over into cannabis after using it medicinally. Current projects include investigations into cannabis and wellness; entrepreneurs of the Green Rush; cannabis for athletes; and the evolution of cannabis laws and culture in Canada.