Washington – For the first time ever, the U.S. Food and Drug Administration has approved a marijuana-derived drug.
In an announcement Monday, the FDA said they have approved Epidiolex (cannabidiol) oral solution.
This drug is a treatment option of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.
Not only is the first marijuana-derived drug approved by the FDA, but the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
The component in this newly approved drug is CBD (cannabidiol), which is part of the sativa marijuana plant. This drug does not contain THC, which is the part of the marijuana plant that would get someone high.
“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. And, the FDA is committed to this kind of careful scientific research and drug development,” FDA Commissioner Scott Gottlieb, M.D, said.
Right now in Texas under the Texas Compassionate Use Act, epilepsy patients are the only one allowed to get a prescription for CBD oils from three state-approved dispensaries.
Our families have been waiting for this exciting announcement," CEO of Epilepsy Foundation Central and South Texas, Sindi Rosales said. "Epidiolex has been studied and proven to significantly reduce seizures so, in a few short months, it will be a new and welcome product for doctors to consider for their patients in need."
The FDA is approving this new drug, despite it still being considered a Schedule 1 drug by the Drug Enforcement Agency.