FDA Approves Marijuana-Based Drug To Treat Severe Epilepsy
The Food and Drug Administration is approving a marijuana-based medication to treat two rare seizure conditions associated with developmental issues.
The government agency gave the green light this week to an oral solution called Epidiolex to treat Lennox-Gastaut syndrome and Dravet syndrome in those ages 2 and up.
The drug contains cannabidiol, or CBD, a substance derived from marijuana, but causes no intoxication, euphoria or “high,” the FDA said. This is the first time the agency has approved a medication with an active ingredient that comes from marijuana.
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Lennox-Gastaut syndrome and Dravet syndrome are both rare conditions that develop in childhood involving frequent seizures. The FDA said Epidiolex was tested in three clinical trials involving 516 people with the syndromes and was found to be effective at reducing the frequency of seizures better than a placebo when taken in conjunction with other medications.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” said FDA Commissioner Scott Gottlieb.
Dravet syndrome typically becomes apparent during the first year of life and is marked by frequent seizures as well as weak language and motor skills, hyperactivity and social difficulties.
Meanwhile, Lennox-Gastaut syndrome often emerges between ages 3 and 5. Those with the condition have frequent seizures and nearly all develop learning issues and intellectual disability.
“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
For years, families of children with severe seizure issues have been turning to marijuana-based substances to find relief from debilitating episodes, often skirting the law to obtain what they said was their only effective treatment option. More recently, some families have moved to states that have legalized marijuana in order to gain regular access.
The FDA took pains to specify that clearing Epidiolex for use is not an approval of marijuana or any of its components.
The agency will continue to support research on potential medical uses of the drug, but is “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims,” Gottlieb said.