For the first time in the U.S., a cannabis-based medicine has been approved by the FDA.
Yes, synthetic THC has its stamp of approval, but Epidiolex is different. The new drug is made from natural cannabidiol (CBD), the non-psychoactive component of cannabis that provides medicinal relief without a high. Epidiolex, suitable for patients aged two and older, targets one of two rare forms of epilepsy: Dravet syndrome, for which no other approved medicine exists, and Lennox-Gastaut syndrome.
Researchers have gathered an exhaustive body of research on cannabis’s potential to treat epilepsy. And after years of its own testing, this particular anti-seizure medication speaks for itself: patients have seen an average 40 percent drop in seizures.
There’s just one loose end to tie up before patients can get Epidiolex by prescription.
CBD Could Save Lives, the FDA Finally Admits
Epidiolex’s approval, says its U.K.-based manufacturer GW Pharmaceuticals, is a “much needed, novel medicine” for patients with Lennox-Gastaut and Dravet syndromes. Most are resistant to anti-seizure drugs, while some suffer from dozens of debilitating, uncontrollable seizures a day. One in five dies before their 20th birthday.
The FDA agrees this drug adds significant value to the limited options for epilepsy treatment, and its decision to approve the drug has been in the pipeline for a while. But before GW can market Epidiolex, there’s the issue of classification to deal with.
At the moment, though CBD products are available in medical cannabis dispensaries across the country, the Drug Enforcement Administration (DEA) still classifies CBD as a Schedule I drug. On a federal level, this confines CBD to a category of drugs with no medical value and a high risk of abuse, despite years of research suggesting the cannabinoid is an important medical advancement.
The DEA now needs to reclassify CBD, but it’s too early to guess how it will do so. The Administration could either make CBD a legal pharmaceutical under Schedule II or III while keeping cannabis a Schedule I drug in general, or, less likely, de-schedule cannabis entirely. It has 90 days to decide.
Either way, “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,” said FDA Commissioner Scott Gottlieb. “And the FDA is committed to this kind of careful scientific research and drug development.”
Of course, none of this changes the fact that CBD oils and CBD-based cannabis strains are already available – right now – for use if you are a medical marijuana patient in certain states, including Massachusetts. As has been the case for years, it remains the federal level that has to catch up.
One Small Step for CBD, a Giant Leap for the Industry?
Though Epidiolex was only approved for the two specific conditions – which afflict fewer than 45,000 people in the U.S. – experts say doctors may eventually prescribe it for other types of epilepsy, too.
Not only that, but Gottlieb hopes to use Epidiolex as a model for future cannabis-based drug development. He was careful to note that the approval of Epidiolex doesn’t mark the approval of CBD or medical cannabis in general; it’s one specific form of CBD for specific uses in approved dosages. But the FDA is open to considering similar drugs, as long as their makers prove they are safe.
Of course, FDA’s approval validates what we already know: that cannabis has tremendous therapeutic value. This is why high-CBD products have been safely used and readily available at dispensaries for decades. But until now, not all patients have had access. If we can standardize therapies like Epidiolex, families won’t have to move states just to treat their children legally.
The DEA’s impending decision is just one variable of many that will determine Epidiolex’s impact on the industry. But experts hail its approval a major step forward. The FDA has opened doors for serious testing of life-saving cannabis medications, and that at least has been a long time coming.