The 13-0 vote from the FDA advisory committee is not binding, and the agency will announce its decision by the end of June. But in documents this week, FDA officials wrote they supported the approval of the drug, Epidiolex, as it cut the number of seizures in patients in clinical trials.
Marijuana: What Is Epidiolex?
Epidiolex, as an oral solution, consists of cannabidiol (CBD), a component of cannabis that does not make people high. Its manufacturer, GW Pharmaceuticals, is seeking its approval to treat Lennox-Gastaut and Dravet syndromes. These two conditions typically emerge in the first few years of life. Patients suffer from severe seizures, and 20 percent of patients die by the time they are 20 years old.
In clinical trials, patients taking Epidiolex saw their monthly seizures reduced by about 40 percent.
Some patients in the trials experienced sleepiness or gastrointestinal issues. Also, the medication did not work for all patients. In addition, there is some concern about the effect of the drug on the liver. But, tracking liver function during treatment would control such side effects. Three clinical trials provided robust data.
Marijuana: Emotional Parents Testify
In sometimes emotional testimony, the parents of children with the conditions urged the panel and FDA to get the drug to the market. They described how they have to watch their children constantly, and the horror of their children’s seizures. These seizures can be so violent they break bones. They explained the developmental setbacks their children faced and the problems with other medications and therapies.
After receiving Epidiolex, seizures went from 40 to 50 a day to only a few or none per week.
Some families have moved to states where medical marijuana is legal in order to obtain CBD oil for their children’s epilepsy. But experts say it is important to have an approved and regulated medication available in a standard dose. Irregular doses, substandard supplies, run the risk of side effects without medical supervision.
Marijuana: Current Drug Classification
The Drug Enforcement Administration (DEA) continues to classify marijuana as a Schedule I drug. This means it has no proven medical value and a high risk of abuse. Once approved, the DEA will then reschedule cannabidiol since it demonstrates a medical value.