Epidiolex, The First Approved Cannabinoid Based Medicine by the FDA
On June 25, 2018, the FDA made history by approving Epidiolex, a cannabinoid-based drug, for the treatment of epilepsy in children. As reported by Prevention Magazine, on their website, the FDA approved drug uses a purified form of cannabidiol (CBD) oil to treat two rare and severe forms of epilepsy occurring in pediatric patients ages two and older. In clinical trials, Epidiolex, the first cannabinoid approved by the FDA, was found to reduce seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome and did not result in the harsh side effects of typical epilepsy drugs, which can include blurred vision, nausea, and liver problems. CBD is a derivative of cannabis that does not have psychoactive properties, and therefore does not result in a “high.” The cannabinoid drug Epidiolex is being produced by GW Pharmaceuticals.
Prior to the FDA approval of this cannabinoid-based medicine, an amendment to SB17-017 was passed last year, which allows minors to receive medical marijuana, stipulated that two physicians, one of whom must be a board-certified pediatrician, a board-certified family physician, or a board-certified child and adolescent psychiatrist who is part of the family’s medical care team, must prescribe medical marijuana for any person under the age of 18, and each of the patient’s parents residing in Colorado must consent to this treatment in writing to the state health department, with one parent consenting in writing to serve as the patient’s primary caregiver.
FDA Commissioner Scott Gottlieb, MD, made clear in a press conference on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components that the FDA approval of the cannabinoid-based medicine Epidiolex does not signal a sweeping legalization of marijuana in general, stating:
“This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients. This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this cannabinoid drug is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”
Gottlieb emphasized that this is only the first cannabinoid-based medicine approved by the FDA. He hopes this is the first of many advances for treatments like CBD providing medical marijuana product developers cooperate with government drug development programs, stating further:
“Drugs derived from marijuana also are eligible for several programs that are intended to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions. The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels.”
Although CBD is legal in a majority of the country’s individual states, CBD oil is currently still classified as a Schedule I drug with no medicinal value by the Drug Enforcement Administration (DEA). This means that before the drug’s manufacturer can market it to the public, the DEA will need to change its classification for FDA approved drugs.
FDA approval of cannabinoid-based medicine Epidiolex is welcome news to parents of children across the nation who currently suffer from the debilitating effects of epilepsy and is seen as an indication of good things to come for the future of other marijuana-derived medications becoming available for a variety of illnesses and chronic conditions, including other seizure disorders, chronic pain, and cancer. It is not clear whether insurance companies will step up and cover the cost of this cannabinoid drug or future cannabinoid-derived medications that receive FDA approval. Currently, CBD tinctures can be costly, and parents of children with epilepsy are forced to pay out of pocket to fill their legal prescriptions.
If you have questions about the proper application of medical marijuana for your situation, please contact Medical Alternatives Clinics at (719) 246-0393 or email us your questions at: hello@medicalalternativesclinics.com. If you would like to schedule an appointment, please visit our online portal. We offer convenient same day appointments for current and prospective medical marijuana patients, and we can help you get your MMJ Red Card in three days or less!
