FDA Approves First CBD Product
In a landmark decision by the Food and Drug Administration of the United States, the first drug treatment derived from the cannabis family was approved for public consumption. Epidiolex, is an oral solution of cannabidiol created by GW Pharmaceuticals and has been at center of numerous clinical trials whose results prompted the ruling. Being that were a CBD Vape Juice manufacture, this is fascinating news for us.
Epidiolex will be made available to those that need it most as a treatment for severe and rare forms of afflictions among other uses. In fact, it is the first drug ever specifically approved for treatment of the rare disease Dravet syndrome which is a genetic condition accompanied by debilitating effects that can often worsen and require the sufferers to have emergency medical care. As a result, those affected by Dravet syndrome have trouble developing language and motor skills. However, the application of CBD as a treatment for these symptoms could potentially change that for them moving forward.
Additionally, CBD will be approved for the treatment of Lennox-Gastaut syndrome, another medical condition which causes a spectrum of afflictions. This ailment like Dravet syndrome can lead to poor development of the motor skills and learning abilities of the sufferers which often requires them to get help with even the simplest of tasks in their daily lives. Again, opening the possibility for them to both learn and grow at a more manageable level can change the lives of many of those affected for the better.
CBD Dravet Syndrome Treatment Under the Microscope
While CBD has not been approved for a third treatment specifically as yet, Epidiolex is in a phase three clinical trial for another genetic disease with similar effects and symptoms. With this in mind, simply being offered as a prescription medication opens CBD up to be used as a possible treatment for additional medical uses beyond the few it’s already approved for. The medical field refers to this as off-label use, as it is being prescribed by a doctor for a usage other than indicated by the manufacturer and is a common practice in medicine.
This decision by the FDA is the culmination of three double-blind, randomized, placebo-controlled clinical trials involving 516 participants with either of the the aforementioned Lennox-Gastaut or Dravet syndromes. As a result, CBD was proven to reduce the frequency of episodes caused by the rare and debilitating conditions. FDA approval comes on the heels of numerous states passing legislation specifically to allow for CBD oil and oral application for treatment of numerous afflictions associated with the symptoms of these ailments.
That said, CBD is still considered a schedule I drug by the Drug Enforcement Agency due to its association with the cannabis plant. However, it has been granted Orphan Drug status for both primary syndromes and given fast-track status specifically for Dravet syndrome, effectively bumping Epidiolex up on the priority of necessary, potentially life-saving medicines. With this in mind, it’s important to understand that much of the consumer CBD products marketed in the United States that aren’t specifically labeled as “full-spectrum”, contain minuscule (less than 0.3%), if any THC.
What’s the Difference Between CBD and THC?
To explain, tetrahydrocannabinol or THC is the psychoactive component of the cannabis plant, known for providing users with a “high”. Reflexively, hemp-derived CBD naturally contains low amounts of THC which is then extracted to produce an isolate that is 99% pure. Essentially, there is no recreational drug purpose for CBD because it does not act like a mind-altering drug, which is part of what gives it a separate designation legally.
Recently, this has been a legal grey area for regulatory bodies, as the hemp plant is considered an industrial product with no connection to marijuana or its Schedule I status. As a result, CBD extracted from hemp plants is technically legal as it is considered a dietary or vitamin supplement. With that in mind, while many states have legalized both medical and recreational cannabis, products containing THC still remain federally illegal.
However, now that a CBD product has been approved by a federal regulatory body as a medical treatment, there is no end to the possibilities of what ailments cannabidiol can be used as a treatment for. It’s an exciting moment for users of CBD who have been proponents of its possible medicinal properties for years. Though, the real winners here are those affected by these conditions who may now have a more promising future ahead of them.