According to many recent reports, the Food and Drug Administration is close to approving a new prescription CBD oil. Last week, a panel of advisors gave their unanimous approval to Epidiolex, a drug that will be used to treat the severest forms of epilepsy. This will make Epidiolex the first prescription cannabidiol drug on the market.
Per the New York Times, the advisors approved the use of Epidiolex for Dravet Syndrome and Lennox-Gastaut Syndrome. These extreme, treatment-resistant forms of epilepsy wreak havoc on the lives of sufferers. People who suffer from them often continue to have seizures despite conventional medications. These conditions typically appear in toddlers and can drastically influence development, putting them at risk for disabilities and compromised intellect.
Both conditions are uncommon with less than 30,000 people in the US suffering from Lennox-Gastaut and less suffering from Dravet’s. This qualifies Epidiolex for the Orphan Drug Designation program, an FDA program that “provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.”
CBD Versus THC
Most people understand the difference between CBD and THC by now. But, to recap, the difference is striking but simple: CBD does not possess any psychoactive effects; THC does.
THC is often used to “help” CBD do its job. This means some people can get high from CBD products that contain small amounts of THC (others feel nothing). And that, in part, is why CBD remains controversial.
CBD oil is available anywhere – you can literally have it shipped to your house (even if you live in Utah). But this is only if it’s hemp-based. By law, hemp can contain no more than .3 percent THC or, in technical terms, a small enough amount that the government doesn’t care.
Some people swear by this oil and use it religiously; others question how effective it is. The FDA itself makes no claim – check any bottle and the obligatory “this has not been approved by the FDA” will appear.
Epidiolex is a different story.
Not surprisingly, Epidiolex comes from GW Pharmaceuticals, a British company that quickly established itself as a leader in medicinal cannabis. They are most well known for developing Sativex, a medication approved for those suffering from spasticity as a result of Multiple Sclerosis.
As for Epidiolex, GW Pharmaceuticals describes it as follows:
“Epidiolex is GW’s lead cannabinoid product candidate and is a proprietary oral solution of pure plant-derived cannabidiol, or CBD. GW’s Epidiolex development is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS).”
CBD as Treatment for Epilepsy
Of all the medical conditions, fewer have been studied as efficiently as epilepsy when it comes to pot. In fact, even states with weak medical marijuana programs (like Alabama and Indiana) allow for the use of medicinal cannabis to treat seizures and seizure disorders. It appears that they’re listening to the research.
In one study, CBD was found to cut seizures in half for some of those affected by Lennox-Gastaut Syndrome. This study found that nearly “40 percent of people with LGS had at least a 50 percent reduction in drop seizures when taking a liquid form of cannabidiol compared to 15 percent taking a placebo.”
A drop seizure is a type of seizure where the muscle tone changes and the person collapses as a result. People who suffer from LGS have several different types of seizures, including drop seizures and tonic-clonic seizures (which manifest as convulsions). The drop seizures often don’t last long but they can be very dangerous as collapsing to the ground can cause tremendous injury.
The participants in the study had an average of 85 drop seizures per month and had already tried an average of six epilepsy drugs to no avail. Those given the highest dose of CBD experienced a 42 percent reduction in seizures; those given a lower dose (10 mg/day versus 20 mg/day) experienced a 37 percent reduction. The most common side effects experienced included sleepiness and reduced appetite.
The FDA Approval Process
Just because the FDA panel of advisors unanimously approved Epidiolex, there is no guarantee the FDA itself will follow suit: they are not bound to whatever their advisors suggest (though it’s certainly more optimistic that the advisors approved the drug rather than denied it).
GW Pharmaceutical’s presentation before the board involved data from three clinical studies conducted over 14-weeks that demonstrated Epidiolex’s efficiency as well as its side effects. Several patients also spoke up on the drug’s behalf.
The FDA is set to make a final decision on or before June 27.
The approval process is nothing if not arduous. According to the Department of Affairs, it takes around a decade from a drug’s development to its approval for FDA-mandated use (on average). Even after the clinical trials stop, it can still take several months or up to a year for approval.
The FDA does offer an accelerated process which allows for quicker approval. The program is used to “allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measures that are thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.”
Drug companies must commence with clinical trials even with the accelerated approval. If the trials show a benefit, the FDA offers approval. If they don’t, the FDA reserves the right to remove the drug from the market.