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FDA Approves CBD-Based Drug to Treat Seizures

Cannabidiol—aka CBD—is having a major moment in the wellness space. From the best health and wellness CBD products, cannabis-infused pain relief creams, the best CBD oil beauty finds, and even weed lube for better sex, the potent ingredient is just about everywhere. This week, though, it's popping up for first time in the medical community with the announcement of the first FDA-approved CBD medicine for the treatment of seizures.

Derived from CBD oil (refresher: THC is the stuff that gets you high, not CBD), a drug called Epidiolex was just approved to treat seizures in children and adults with two rare but severe forms of epilepsy, both of which typically develop in childhood. Considering the fact that marijuana is still illegal in many states across the U.S., the FDA approval is significant; it marks the first marijuana-based drug to be approved in the country.

Epidiolex is essentially medical-grade CBD oil—a highly concentrated, consistent, and regulated version of the more holistic stuff. Because CBD doesn't get you high, health brands have zeroed in on CBD as an effective way to relieve pain, decrease inflammation, and potentially treat a variety of health conditions—including epilepsy. (Related: Does Cannabis Belong In Your Skin-Care Products?)

But even though the medicinal oil has long been used as an at-home alternative therapy for seizures, neurologists admit that they still aren't quite sure how CBD oil works. "There are several different mechanisms we're exploring right now," says Steven Wolf, M.D., director of pediatric epilepsy at Mount Sinai School of Medicine. "Every anti-epileptic drug's job is to stabilize the nerves from over-firing," says Dr. Wolf. "Each drug that the FDA has approved for seizures works on some aspect of preventing that neuron from firing away like crazy." Based on what neurologists know about epilepsy, for this new drug Epidiolex to accomplish that, CBD likely triggers a reaction in the brain that either blocks certain neurotransmissions or stabilizes neurons, he says.

Dr. Wolf says there's a lot to be excited about with this new innovation and its availability within mainstream medicine. Not only does the FDA-approval open doors for the future of epilepsy treatments, the clinical trials (still ongoing) performed as part of Epidiolex's approval process have also let neurologists explore the broader implications of and possible uses for CBD. "The study really let us learn a lot about CBD in general—including its interaction with other medications and CBD's effect on children," says Dr. Wolf, who adds that the published findings are key resources for doctors treating epilepsy and other seizure-related conditions.

Based on the results of the clinical trial, Dr. Wolf says he's "really optimistic" about CBD's ability to significantly reduce the frequency of seizures in people suffering from these neurological problems. But he emphasizes that CBD isn't a cure-all. Epidiolex didn't stop seizures in all of the patients studied, and more trials will need to be done to explore the effects of CBD on other types of epilepsy. The trials also found that Epidiolex seems to work best when combined with existing epilepsy meds. The bottom line? "I think this is another complementary medication in our armory of anti-seizure medication," says Dr. Wolf.

GW Pharmaceuticals, the drug company behind the breakthrough, will be announcing a public release date for Epidiolex, which hopefully includes cost information, in the next few months. It's not likely to be cheap—analysts have predicted Epidiolex could cost a staggering $25,000 per year as compared to the $1,800 the average family treating epilepsy spends on other forms of CBD, according to a report by CBS.

Cost aside, the approval does send a strong message from the FDA about the place of medical marijuana, CBD, or other derivatives in the future of medicine. "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," Scott Gottlieb, M.D., FDA commissioner, said in a press release. "The FDA is committed to this kind of careful scientific research and drug development."

 

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