The first Food and Drug Administration-approved drug containing an ingredient derived from the marijuana plant went on sale Thursday in the United States.
Epidiolex is a twice-daily oral solution — a cannabidiol, or CBD liquid — made by Britain-based GW Pharmaceuticals. It is approved for use in patients 2 years old and older with two types of epileptic syndromes, Dravet syndrome and Lennox-Gastaut syndrome.
“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures,” Justin Gover, CEO of GW Pharmaceuticals, said in a written statement.
The FDA approved Epidiolex in June. CBD is derived from the cannabis plant but it does not create any “high” in users. CBD oils and other CBD products have become popular across the United States in recent years, for the treatment of pain and other issues.
This was the first time the FDA 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 FDA advisory panel unanimously recommended in April that Epidiolex be approved for use in the United States.
Low doses proved effective
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.
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.