Though medical marijuana advocacy and legalization remains an ongoing issue in many states, the key compounds recently received a groundbreaking stamp of approval. This past June the FDA approved Epidiolex, a drug derived from cannabidiol (CBD), to treat two rare forms of childhood epilepsy.
Epilepsy patients and their families have long been leading advocates for the reform of medical marijuana laws, and many have even moved to different states to access necessary treatments. With the FDA’s imprimateur, however, Epidiolex will be available to patients across the country.
The CBD Effect
Marijuana has two primary active compounds: tetrahydrocannabinol (THC) and CBD, and the two are very different. THC is the psychoactive component of the drug – what makes people feel “high” when they use marijuana, while CBD is both non-addictive and non-psychoactive.
Rather, CBD binds to a number of sites throughout the body and, where it’s legal, the substance has been used to treat anxiety, Alzheimer’s, and migraines, in addition to epilepsy. The greatest challenge for patients is that medical marijuana laws authorize its use for different conditions depending on the state.
Typically CBD is administered in the form of an oil, though any oil derived from the marijuana plant will contain at least a small amount of THC, though the amount is normally below 0.2%. This scant amount of THC is one of the primary reasons that even CBD-based substances are illegal in the United States. The Drug Enforcement Administration (DEA) considers marijuana a Schedule I Drug, meaning it has no accepted medical use, specifically because it contains THC.
If the CBD from marijuana is used to treat such a broad set of health ailments, why is epilepsy the first to receive the FDA’s stamp of approval? One central factor in the FDA’s decision is that Epidiolex isn’t just for epilepsy, but it treats Lennox-Gastaut syndrome and Dravet syndrome, two very rare forms of epilepsy that result in frequent seizures. These conditions don’t respond to the broad group of epilepsy medications used for other forms of the seizure disorder.
Many individuals with Lennox-Gastaut and Dravet syndromes can suffer serious brain damage from the constant seizure activity, and they come with added medical issues, including learning and language delays. However, it’s also important to note that the majority of people with epilepsy won’t qualify for Epiodiolex as their symptoms are sufficiently controlled with other medications.
In contrast to those with intractable epilepsy, most other patients use medical marijuana to manage the side-effects of conditions, such as nausea from chemotherapy, muscle spasms in multiple sclerosis, and to manage some of the pain associated with fibromyalgia or neuropathic pain. For epilepsy, though, the CBD compound seems to actually treat the condition.
Every state that offers medical marijuana approves it for intractable seizures; some, like Alabama, only approve marijuana for epileptic conditions and no other purposes. The outcome of the treatment is that dramatic and the options are so limited, making intractable seizures the best test case for a marijuana-based medication.
The Advantages Of Epidiolex
For the families of those with Dravet syndrome or Lennox-Gastaut syndrome, Epidiolex’s approval offers significant advantages. Not only is it an effective treatment for an otherwise very serious disorder, but for patients that had previously relied on CBD oil, the approval of Epidiolex means it’s much easier for patients to travel freely.
Some states consider low-THC CBD oil to be a nutritional supplement with few sales restrictions, while others ban it altogether. As such, when users traveled in the past, they risked violating laws regarding drug possession or running out of the oil and being unable to get more.
The approval of Epidiolex may also serve as a model for medical marijuana activists focused on other conditions. The families of those with Lennox-Gastaut and Dravet syndromes were indispensable in ensuring that Epidiolex went through double-blind trials to prove its efficacy and to establish its safety when used in conjunction with other seizure medications.
Too often, medical marijuana advocates rely heavily on anecdotal experiences of the substance rather than advocating for formal research into the mechanism, efficacy, and safety of CBD for a given condition. Anxious patients want to run ahead of the research.
It’s not just advocates who are likely to be influenced by the approval of Epidiolex. Many researchers who have previously disregarded cannabis-related pharmaceuticals are more likely to express interest in the prospect – and they’re more likely to receive funding.
Until recently, it’s been difficult to find funding streams to support CBD-related research, relying exclusively on private funders. Though federal funding sources are still limited and a source of contention, the success of Epidiolex could transform that field.
The battle over medical marijuana will likely continue over the next several years, but Epidiolex has changed the landscape. Now that the FDA has approved one CBD-based drug, thousands of patients across the country have new hope of legal treatment.