The Food and Drug Administration approved on Monday approved the first-ever prescription drug made from marijuana.
The new drug, Epidiolex, from GW Pharmaceuticals, will be used to treat two rare and severe forms of epilepsy, a neurological disorder that leads to unpredictable seizures.
"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 said in a statement. "And, the FDA is committed to this kind of careful scientific research and drug development."
Epidiolex contains cannabidiol, a chemical component of marijuana. The medication does not contain tetrahydrocannabinol, marijuana’s primary psychoactive component that causes the common high.
With the drug, seizures from epilepsy disorders Lennox-Gastaut syndrome and Dravet syndrome can be better controlled and “have a profound impact” on patients’ quality of life, FDA division of neurology products director Billy Dunn said Monday.
Researchers studied Epidiolex’s effectiveness in three randomized, double-blind, placebo-controlled clinical trials with a total of 516 patients, all of whom suffered with one of the two epilepsy conditions.
Common side effects of Epidiolex, according to the FDA, include:
- Sleepiness
- Sedation
- Lethargy
- Elevated liver enzymes
- Decreased appetite
- Diarrhea
- Rash
- Fatigue
- Malaise and weakness
- Insomnia
- Sleep disorder/poor quality sleep
- Infections
The most serious risks of the drug include thoughts of suicide, aggression, panic attacks, depression (new or worsening) and agitation. Side effects may also raise possibility of rare but more severe liver injury.
More information on the announcement is at the FDA website.
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