The U.S. FDA approved on Monday the first prescription drug that is made from marijuana. The drug is called Epidiolex, and it can treat two forms of epilepsy that begin in early life.
The drug is a syrup with a strawberry flavor, containing a purified form of a chemical found in the cannabis plant, cannabidiol (CBD). CBD reduces seizures in people with epilepsy.
So far, research into cannabis has been very difficult, but the British drugmaker GW Pharmaceuticals finally overcame the legal hurdles and got to study the effects of the drug in over 500 children and adults that had critical seizures.
According to the FDA officials, the drug can reduce seizure, if combined with existing epilepsy drugs.
A Better Product for Physicians to Prescribe
Parents already use CBD oil to treat their children with epilepsy, so Epidiolex is a pharmaceutical-grade type of CBD oil. The chemical does not contain THC, the ingredient that affects the brain.
Physicians are happy to find a regulated version of the product. Dr. Elaine Wirrell is the director of the Mayo Clinic’s program for childhood epilepsy, explaining why they’re pleased with the FDA approval of Epidiolex:
“I’m really happy we have a product that will be much cleaner and one that I know what it is. In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”
Some of the side effects of the drug are diarrhea, vomiting, fatigue and sleep problems.
FDA Commissioner Scott Gottlieb said that the agency would scrutinize CBD products that have “uncertain dosages and formulations,” stating that:
“We are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.”
The FDA approved Epidiolex to be used for patients that have Dravet and Lennox-Gastaut syndromes, the two rare forms of epilepsy that have a limited treatment. However, doctors can prescribe it for other uses.
The DEA Must Reclassify Marijuana – It Has Medical Benefits
The U.S. Drug Enforcement Administration (DEA) categorizes marijuana into Schedule 1 substances, along with heroin, which is both considered deadly and believed to have no medical benefits. So, the DEA must reevaluate the drug and classify it as a substance with medical properties, so that GW can sell it.
According to the GW Pharmaceuticals spokeswoman, the company will launch the product in the fall but haven’t announced a price for it.
Andre Blair s is the lead editor for Advocator.ca. He holds a B.A. in Psychology from the University of Toronto, and a Master of Science in Public Health (M.S.P.H.) from the School of Public Health, Department of Health Administration, at the University of North Carolina at Chapel Hill. Andre specializes in environmental health, but writes on a variety of issues.