A couple of months before the U.S. Food and Drug Administration (FDA) approved a drug containing marijuana, Forbes anticipated it and published the opinion of an advisory panel that evaluated it. The FDA had convened a meeting of experts to get their opinions on whether to approve a “marijuana-based drug” that treats “rare forms of epilepsy.” The 13 members of the panel voted unanimously to recommend approval. One panelist described his decision as “a no-brainer for me,” and others expressed “negligible” concern about the safety of the drug Epidiolex that contains a “pharmaceutical-grade form of cannabidiol (CBD).”
Qualifying as a Drug
With the approval of the first drug derived from marijuana by the FDA, an “oral solution” that treats seizures that occur in two “rare and severe” forms of epilepsy became available. It targets two syndromes, Lennox-Gastaut and Dravet, that can affect two-year-olds and older patients. The landmark decision represents the first approval by the FDA for a drug that contains a purified “substance derived from marijuana.”
Epidiolex provides the first drug that can treat patients who have the Dravet syndrome. Both syndromes that the drug treats start in early childhood with multiple types of seizures that present resistance to existing drugs. While six drugs have approval for treating Lennox-Gastaut syndrome specifically, none existed for Dravet syndrome until the FDA decision. Statistics from the National Institutes of Health show that Lennox-Gastaut syndrome affects “30 million people in the United States.” Even at that rate of frequency, the condition accounts for “less than 5 percent of all cases of childhood epilepsy,” and if affects more males than females. Dravet syndrome afflicts about 6,000 American children.
Gaining Approval
The Controlled Substances Act (CSA) classifies CBD as a Schedule I substance because of its derivation as a “chemical component of the cannabis plant.” The CSA established U.S. drug policy that regulates the use and distribution of hallucinogenic and other substances. Drugs that carry a Schedule I designation have a significant potential for abuse, no accepted “medical use” and “a lack of safety” for use under medical supervision. The strict rules of classification emphasize the significance of the FDA’s approval of a drug that contains a form of CBD. Other drugs in Schedule I include heroin, LSD, ecstasy, methaqualone and peyote.
The decision by the FDA to approve Epidiolex confirms it as a drug. While CBD exists as a compound in “very small quantities in the marijuana plant,” it has attracted the interest of the scientific community and the public for years. Its therapeutic benefits and anti-seizure properties have kept it at the center of attention as an alternative for treatment that may bring relief from symptoms of seizure disorders.
Understanding the Manufacturing Process
The London-based manufacturer, GW Pharmaceuticals, stated that the drug “contains only trace amounts of THC” that lets pot smokers get high. The company grows the type of marijuana plants that produce high levels of CBD and not much THC in their greenhouses in England. A manufacturing process purifies the oil. Justin Gower, the company’s chief executive, said that “the plant itself and the processing steps” create a product that “ends up as pure CBD.”
