FDA Approves Epidiolex, First CBD-Based Drug for Epilepsy
A year ago
Medical marijuana users take note: The FDA has just approved a new drug containing cannabidiol (CBD). Its aim is to treat two rare, severe forms of childhood epilepsy.
Researchers studied Epidiolex’s effectiveness in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either syndrome. Epidiolex, taken with other medications, was effective in reducing the frequency of subjects’ seizures.
This is the first time that the U.S. government has given the green light to a drug derived from CBD. Though CBD is a cannabis compound, it’s non-psychoactive, unlike the other famous cannabinoid, tetrahydrocannabinol (THC).
“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. And, the FDA is committed to this kind of careful scientific research and drug development,” says FDA Commissioner Scott Gottlieb in a news release.
The announcement has led to speculation among experts that a new wave of approved cannabis-based medications may be coming.
“This is a very good development, and it basically underscores that there are medicinal properties to some of the cannabinoids,” says Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California San Diego, in a New York Times interview about Epidiolex.
Epidiolex Pushes CBD Legalization
Epidiolex may become available this fall, but it still has hurdles to clear. One potential roadblock is an investigation into its potential side effects. Also, despite the FDA approval, CBD remains federally illegal. The DEA classifies it as a Schedule 1 drug, defined as “drugs with no currently accepted medical use and a high potential for abuse.”
But with Epidiolex’s FDA approval, the DEA may reclassify CBD over the next three months. This will make it possible for patients to purchase the drug with a doctor’s prescription. Already, some drugstore chains such as Rite Aid say they’ll carry it.
But Does This Mean Cannabis Could Become Legal?
If CBD gets DEA approval and is put under a new schedule, that doesn’t mean cannabis as a whole will get the green light any time soon. Federal authorities seem to be sticking to a policy of marijuana prohibition, even though a majority of Americans are in favor of legalizing the plant.
The government only seems to be considering and testing individual cannabis compounds one at a time. Marijuana has so many different compounds and strains that with the government’s current stance, it’s hard to imagine whole cannabis receiving a general stamp of approval.
CBD got FDA approval because it’s an isolated extract that’s been thoroughly studied and tested. It underwent even more testing during the development of Epidiolex, and the drug will meet strict manufacturing standards.
In fact, Gottlieb warns against other cannabis-based medications making similar claims without this kind of disciplined development: “We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high-quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.”
It’s worth noting that once given the final go-ahead, Epidiolex will be treated like a traditional pharmaceutical. It will be available through licensed pharmacies, but not at dispensaries where many people currently get their medical marijuana.
Exploring New Medical Applications of Cannabis
Caution aside, researchers are keen to explore the medical uses of CBD, as well as the potential of tetrahydrocannabinol (THC) and the other 400 or so compounds found in cannabis. There’s already a growing library of research that shows CBD’s potential in treating:
- Parkinson’s disease
- Multiple sclerosis
- Tourette’s syndrome
The list of potential applications for diseases and conditions is nearly endless.
For its part, GW Pharmaceuticals has also developed a new CBD-based nasal spray, Sativex, that relieves pain and has been approved by the British government.
“Advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” says Gottlieb.
Not All CBD Medications Are Created Equal
“Sound development” is the key here. Gottlieb and other medical experts warn that not all CBD-based medications are created equal.
In states where cannabis is legal, or in ones that have laws legalizing CBD only, CBD-infused oils and salves are sold through dispensaries. A 2017 study published in the Journal of the American Medical Association found that the levels of CBD contained in products from 31 different sellers were often different than the amounts shown on labels. And in some cases THC was present, even though it wasn’t listed.
That said, you can’t put the genie back in the bottle. The testimony of people who have successfully used non-prescription CBD to treat childhood epilepsy and other conditions is hard to ignore. And given the choice between paying to go see a doctor for an expensive prescription or getting CBD from their usual supplier, people will often go with what they know and trust. Hopefully, Epidiolex is just the beginning of regulated, effective CBD medicine that will be made available to those who need it.
Photo credit: Annie Spratt