FDA OKs First Drug Containing CBD
MONDAY, June 25, 2018 (HealthDay News) — In a regulatory first, the U.S. Food and Drug Administration on Monday said it had approved a drug with an ingredient derived from the marijuana plant.
In a statement, the agency said it had “approved Epidiolex [cannabidiol, or CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older.”
CBD is derived from the cannabis plant but it does not create any “high” in users. CBD oils and other CBD products have become highly popular across the United States in recent years, for the treatment of pain and other issues.
This is the first time the FDA has approved such a product for any medicinal use, however. In a statement, agency Commissioner Dr. Scott Gottlieb said regulatory approval and oversight is important to safeguard patients.
“Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery,” he explained.
An advisory panel for the U.S. Food and Drug Administration unanimously recommended in April that Epidiolex be approved for use in the United States.
More approvals to come?
Although CBD oil has become a trendy cure-all, treatment of epilepsy is the only use that has garnered significant scientific evidence supporting its usefulness.
And Gottlieb stressed that numerous marijuana-linked medicines are not necessarily poised for release into the marketplace.
“We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products,” he said. “But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
Epidiolex made headlines in May when a clinical trial found that even low doses of the drug could help patients with epilepsy.
In the trial, patients taking a 10-milligram (mg) daily dose of pharmaceutical-grade cannabidiol experienced nearly as great a reduction in seizures as patients on 20 mg, and with fewer side effects, said the lead researcher of that study, Dr. Orrin Devinsky. He directs NYU Langone’s Comprehensive Epilepsy Center in New York City.