- The cannabis-based drug can be used to treat epilepsy.
- The drug can be used by children as young as two years old who suffer from Dravet Syndrome and Lennox-Gastaut Syndrome, rare childhood-onset forms of epilepsy.
The drug's approval permits its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.
The drug, Epidiolex, is derived from cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.
Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effects and has been cited by scientists as a potential treatment for mental health issues.
"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.
While Monday's approval makes Epidiolex the first cannabinoid-based prescription medicine approved in the United States, drugs with a synthetic version of molecules derived from marijuana have been approved.
In 1985, the FDA signed off on Marinol, which contains a synthetic version of THC, to treat loss of appetite in people with AIDS.