The FDA Just Approved This Once-Illegal Product
By Julie Ricevuto |
Updated Post June 27, 2018:
It's official: The Food and Drug Administration (FDA) has approved the first prescription drug containing cannabidiol (CBD), one of the many components found in marijuana. The drug, which is intended to treat epilepsy, is a major move for the FDA because no other part of the marijuana plant has ever gotten a positive reaction from the agency in the past.
"This is an important medical advance," FDA Commissioner Scott Gottlieb, MD, said in a statement. "But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use." Now that CBD has been approved for this particular medication, Gottlieb is calling for additional research on the ingredient. After all, this new approval may open doors for future medications containing CBD.
Original Post April 20, 2018:
Great news for those interested in the medicinal marijuana industry: Experts summoned by the Food and Drug Administration (FDA) have just unanimously voted that the agency should approve the first cannabidiol (CBD) medicine to treat a rare form of epilepsy, NBC News reports.
The drug, known as Epidiolex, was developed by a British company named GW Pharmaceuticals and is specifically formulated with marijuana-derived, purified CBD. "It's very important to highlight that the drug used in this study, cannabidiol, was derived from cannabis plants, and purified to 99 percent purity," Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center, told NBC News, later clarifying that no THC—which is found in medical marijuana—is used in this product.
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The specific forms of epilepsy—Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome—that Epidiolex is formulated to treat are extremely rare and sometimes fatal, which is why the push for this drug is currently so strong.
As part of its case for approval, GW Pharmaceuticals presented three clinical studies that demonstrate the effects of Epidiolex. Two of the studies were for patients with LGS and the other for patients with Dravet syndrome. The research revealed that the CBD product reduced seizures in both LGS and Dravet syndrome patients by upwards of 40 percent—a dramatic improvement for people whose entire life is overwhelmed by multiple seizures per day.
While there are risks associated with the drug—most notably drug-induced liver injury—the FDA claims their analysis found the possible damage was an “acceptable” hazard because these forms of epilepsy are extraordinarily debilitating and ultimately life-threatening. Plus, the occurrence of liver injury was found to most likely occur much later in life.
Although the FDA doesn’t have to err in favor of the expert advisory panel votes, past examples prove they typically do anyway. Thankfully, the agency has decided to review Epidiolix on an expedited timeline, and the final decision is set to be announced in June.