FDA Approves Epidiolex as a Marijuana Prescription for Epilepsy
In June 2018, the U.S. Food and Drug Administration (FDA) cleared the way for Epidiolex, a cannabis based medication for epileptic patients, making history in the process.
This is the first time the FDA has ever approved a drug derived directly from marijuana.
Marinol (dronabinol) is a prescription pill that been approved by the FDA to treat certain conditions such as the side effects of cancer and AIDS treatment, but it is a synthetic medication and is not derived from marijuana like Epidiolex.
Despite a number of states, such as California, Alaska and Colorado among others, that allow for recreational and medicinal marijuana consumption, cannabis remains listed as a Schedule I drug, along with heroin, cocaine and MDMA, by the Federal Drug Enforcement Agency (DEA).
This has created a lack of research for, and approval of medications made from the cannabis plant.
“This is a very good development, and it basically underscores that there are medicinal properties to some of the cannabinoids,” Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California San Diego, told the New York Times.
What is CBD Cannabidiol and Epidiolex?
According to the FDA, Epidiolex is made from Cannabidiol (CBD) and is an “oral solution for the treatment of seizures associated with two rare forms of epilepsy, Lennox-Gastaut Syndrome and Dravet Syndrome, in patients two years of age or older.”
CBD is one of the lesser known cannabinoids in marijuana, the most famous being THC, which is the psychoactive ingredient in cannabis that leads to users experiencing a “high.”
Moreover, the human body already contains cannabinoid receptors, known as CB1 and CB2. The latter receptor, most often found in the human immune system, is associated with pain and inflammation.
“It used to be thought that CBD acts on these CB2 receptors, but it appears now that CBD does not act on either receptor directly. Instead, it seems to influence the body to use more of its own cannabinoids,” writes Medical News Today contributor Jon Johnson.
What are the Medicinal Benefits of CBD?
Even with a shortage of research, due to antiquated federal drug laws, some healthcare experts are well aware that CBD has several medicinal benefits, which include some of the following:
- CBD can reduce chronic inflammation, which leads to pain, by a considerable amount, a study published in the Journal of Experimental Medicine found
- CBD has anti-seizure properties, which obviously makes it a useful form of treatment for epileptics
- Patients with certain anxiety disorders, such as depression, post-traumatic stress disorder or panic disorder, have shown improvement with CBD treatment
- Additional research suggests CBD might benefit cancer patients, people with type 1 diabetes, patients with Alzheimer’s Disease, skin conditions and even people trying to recover from addiction to opioids, nicotine and other addictive substances
Charlotte’s Web CBD
Perhaps one of the most well known brands of CBD is Charlotte’s Web. Developed by a Colorado grower for a young girl, Charlotte, who suffered debilitating and chronic epileptic seizures as a result of Dravet’s syndrome, it contains almost no THC at all.
Most strains of CBD have some THC, though not always in a quantity that will cause users to experience psychoactive side effects.
Other strains of CBD products come with higher amounts of THC so users will experience both the “high” and the health benefits.
What makes Charlotte’s Web such a unique strand is its nearly pure CBD content, which removes the likelihood that users will experience any negative side effects from THC.
The strain is still rare and found mostly in Colorado, though with the FDA’s approval of Epidiolex, CBD is quickly becoming a medication that healthcare experts see as effective for a number of physical and emotional conditions.
Dr. Maria Roberta Cilio, who works at the UCSF Benioff Children’s Hospital, developed the compassionate-use clinical trial that led to Epidiolex’s approval.
The trial showed a 36.5 percent reduction in seizures for the 162 children and young adults that participated in the study, which was spread out over 11 different epilepsy centers in the United States.
“I feel that we followed the right path that was not easy,” Dr. Cilio told the San Francisco Chronicle. “I was not pro, and I was not con, about marijuana. I took it as I would have done any other drug. I wrote a protocol that was strict and rigorous and accurate, and this is the reason the FDA approved it for the first time.”
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