First prescription CBD product approved in U.S.
United States FDA (Food and Drug Administration) officials on Monday authorized Epidiolex, the first prescription medication incorporating CBD. A major advantage here is that it opens the possibility of drug insurance plans helping to pay for CBD-based treatment.
Another plus is the additional guarantee of consistent product quantity and quality, which is often an issue with common products made with CBD oil rather than lab-tested CBD isolate. “In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it” said Ellaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy.
GW Pharmaceuticals, the producer of Epidiolex, plans to continue importing the medication, bypassing burdensome U.S. regulations currently limiting the manufacture of products which use U.S. grown industrial (non-THC containing) hemp as a feedstock.
Allison Hendershot whose 13-year-old daughter, Molly, has suffered from severe seizures since she was 4 months old had considered transferring her family to Colorado, one of the initial states to legalize marijuana as well as residence to a large network of CBD manufacturers and providers. After learning about a clinical trial of Epidiolex at New York College she decided to remain in Rochester, New York to allow her daughter to participate in the trial. With Epidiolex Molly has had fewer seizures and improved concentration.
CBD containing products are currently sold online and in specialty shops throughout the U.S. For legal compliance most producers extract their CBD oil or isolate from industrial hemp, a plant in the cannabis family that contains little THC, which is the psychoactive component of marijuana and which can be legally farmed in a number of states for clothing, food and other uses.
The only use for which the new drug is officially approved is for the treatment of patients with Dravet and Lennox-Gastaut syndromes, which are two forms of epilepsy. However off-label prescriptions are allowed since while a drug is studied and approved for one or several very specific uses there are usually other uses.
Buproprion, sold under the trade name Wellbutrin, for example, was approved for and sold as an anti-depressant. To use it for smoking cessation would have been an off-label use. Of course once the studies were done it could then be sold specifically for use in smoking cessation under the trade name Zyban.
A GW Pharmaceuticals spokeswoman declined to predict a price for the medication, which it expects to release in the Autumn. Estimates by Wall Street analysts set the probable cost at $25,000 per year, with annual sales eventually approaching $1 billion.
By George Bennet,