June 26, 2018
Epidiolex, a newly developed cannabis-based drug used to treat symptoms of epilepsy, has just been approved by the U.S. Food and Drug Administration, marking the first time the agency has approved a drug derived from the marijuana plant.
The FDA officially approved the drug Monday after a recommendation for approval was issued in April.
"The FDA has an active program to assist drug developers who want to investigate marijuana or its components through properly controlled clinical trials, to demonstrate the potential for safe and effective uses," the FDA said in a statement.
"This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients."
Though the drug is cannabis-based, the plant itself doesn't offer the high associated with using marijuana. According to GW Pharmaceuticals, the UK-based biopharmaceutical company creating Epidiolex, the newly approved drug is the "first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD) ... and the first in a new category of anti-epileptic drugs."
Epidiolex is designed to treat symptoms including Dravet syndrome, a genetic brain dysfunction that begins in infancy, and Lennox-Gastaut syndrome, which causes seizures in patients beginning ages 3 to 5.
Cannabidiol is only one of 80 types of active cannabinoid chemicals. Others, such as tetrahydrocannabinol (THC), produce a high resembling the effects of marijuana.
Epidiolex does have one side effect that is often associated with smoking weed: sleepiness. The side effects are more severe, however, when the drug is taken with other medications.
The drug will become available in the fall. The cost has not yet been revealed, but GW officials are reportedly in talks with insurance companies.