A chemical derived from marijuana has become the first of its kind to be approved by the Food and Drug Administration and will be delivered to patients suffering from epilepsy in the form of a strawberry-flavored syrup.
The FDA announced Monday that it had approved the drug, cannabidiol, which is one of 80 active chemicals in marijuana, to treat seizures from epilepsy. It is the first time the agency has approved a purified drug substance that comes from marijuana.
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The drug, which is formally known as Epidiolex, will be allowed to be prescribed to infants as young as age 2 for Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy.
It is made by GW Pharmaceuticals, a company based in the United Kingdom.
Prior to the approval of Epidiolex, Dravet syndrome had no known treatment. It is a rare genetic condition that causes seizures and fevers in the first year of life, followed by involuntary muscle spasms later in life. Children who have the syndrome often need medical care and have difficulty speaking and moving throughout their lives.
The drug has not shown signs of creating similar high-inducing effects as marijuana, which is caused by a different chemical known as THC, which stands for tetrahydrocannabinol. Side effects from Epidiolex include sleepiness, elevated liver enzymes, decreased appetite, diarrhea, rash and infections.
The FDA said suicidal thoughts and actions were the most severe side effects, which are also observed in other drugs that treat epilepsy.
Some parents of epileptic children use raw marijuana or other products that contain high-inducing THC, finding that coupling CBD with THC yields better results.
In announcing the approval of the drug, FDA Commissioner Scott Gottlieb said other companies looking at medical marijuana options could consider similar approval processes.
“Before a high-quality drug can be developed, evaluated, and eventually approved by the FDA, it’s critical that the necessary work is done to identify drugs of potential medical benefit and conduct rigorous scientific research through adequate and well-controlled clinical trials,” he said. “This is true for all drugs, including ones derived from plant materials, like marijuana.”
He warned that the FDA continues to be concerned and would take action against certain companies marketing pills or oil drops containing cannabidiol and making false claims about their ability to treat diseases.
Marijuana is illegal under federal law, though states have moved to decriminalize it for medical or recreational use.
Steven Nelson contributed to this report.
