Over 500 patients evaluated prior to approval
The United States Food and Drug Administration (FDA) has given its approval to a purified formulation of cannabidiol (CBD) (Epidiolex oral solution) for the treatment of seizures related to two rare forms of epilepsy in patients older than 2 years of age.
The two types of epilepsy indicated are Lennox-Gastaut syndrome and Dravet syndrome.
“This is the first FDA-approved drug that contains a purified drug substance derived from marijuana,” the agency announced in a press release. “It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.”
“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,” FDA Commissioner Scott Gottlieb, MD, said in the same release. “The FDA is committed to this kind of careful scientific research and drug development.”
Over 500 total patients were evaluated across three randomized trials in investigating the effectiveness of the new drug. All evaluated patients had either Lennox-Gastaut syndrome or Dravet syndrome.
Thanks to these trials (available in the New England Journal of Medicine and Lancet) “prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes,” Gottlieb concluded.