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The FDA Just Approved the First-Ever Cannabis Based Drug in the U.S.

June 25, 2018, 3:28 PM UTC

The Food and Drug Administration (FDA) for the first time approved a drug directly derived from cannabis on Monday, Epidiolex, developed by the British GW Pharmaceuticals.

Although several states have legalized the medical and recreational use of marijuana, the federal agency had yet to do so until today. Under the Controlled Substances Act, marijuana is a Schedule I drug, meaning it has a high potential for abuse and no recognized medical purpose (heroin, LSD, and ecstasy are also Schedule I drugs). A bill was introduced to the House last year to legalize the use of marijuana, but it has yet to reach the floor for vote.

The active ingredient in Epidiolex, an epilepsy medication, is cannabidiol (CBD), one of the two main chemical compounds found in marijuana. While CBD has purely medicinal purposes, the other compound, tetrahydrocannabinol (THC), is what gives marijuana users the psychoactive effects commonly associated with the plant. Epidiolex contains less than 0.1% of THC.

An FDA advisory panel recommended the approval of Epidiolex last April, specifically for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two serious and rare forms of epilepsy that appear at an early age. The agency ultimately approved the therapy for both conditions in children two years of age or older on Monday. Nearly all patients with these conditions continue to have daily seizures—some having multiple per day—despite the use of legally available drugs. This can be serious for children, as it can lead to intellectual and developmental disabilities, or even death.

GW Pharma’s Epidiolex has shown promise in epilepsy-related disorders.Courtesy of GW Pharma
Courtesy of GW Pharma

An estimated 30,000 children and adults suffer from Lennox-Gastaut syndrome, and fewer from Dravet syndrome. With the approval, Epidiolex is expected to be available on U.S. markets by September and become a $1 billion-plus seller.

While the FDA had not previously approved any drug directly deriving from marijuana, it has marketed some containing a synthetic version of THC. According to the agency’s website, the FDA “is aware that there is considerable interest in [marijuana’s] use to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders.”

Update: This post has been updated to reflect that the Food and Drug Administration approved Epidiolex on Monday, two days ahead of the deadline.