The journey to FDA approval of Epidiolex (Greenwich Biosciences, www.epidiolex.com), a purified Cannabidiol (CBD) extract from Cannabis sativa is a fascinating story, and is instructive of the potential for healing found in cannabinoids. It is important to study the Epidiolex story, because it establishes a hard baseline for the safety profile of CBD, and the potential for other FDA approved drugs from Cannabis. It also informs the supplement industry, which we are a part of.
Cannabidiol (CBD) has been known to control seizures for some time now, especially in epileptic children. One of “Medicinal Marijuana’s” greatest success stories was of the ability of cannabinoid extracts to quell seizures in young children.
For example, the story of the Marijuana strain Charlotte’s Web, a THC-deficient strain of Cannabis sativa, is one of salvation and healing. Originally called “Hippie’s Disapointment”, this low-THC strain saved the life of a child with severe epilepsy. It was re-named “Charlotte’s Web”, after the child’s favorite book. It turned out that Charlotte’s Web was rich in CBD.
Because of the recent evolution of hemp-derived CBD in law and in practice, CBD awareness has exploded in both the public and private spheres. Private investment in research of CBD, coupled with changes in the law surrounding hemp-derived CBD and the pursuit of clinical trials of CBD by traditional Pharma, have led to the FDA approving a drug for two specific types of childhood seizures, Dravets Syndrome and Lennox-Gastaut syndrome. This milestone in drug development has also established a safety profile for CBD under the most stringent regulation in the world, that of the U.S. Federal Drug Administration. Following this historic FDA approval, highly purified CBD has become available by prescription under the trade name, Epidiolex(R).