The Food and Drug Administration (FDA) recently approved a drug made from Cannabidiol (CBD), a compound in cannabis or marijuana. The FDA approved the drug, which is made by GW Pharmaceuticals, for use in the US by prescription only.
Health authorities approved Epidiolex for the treatment of two forms of epilepsy considered to be rare. This CBD-based drug is said to significantly reduce the number of occurrences of epileptic seizures affecting children with Lennox-Gastaut syndrome and Dravet Syndrome. Frequent and dangerous seizures characterize these two rare forms of epilepsy. Other medications have failed to reduce convulsive seizures of Dravet and the drop seizures in patients with Lennox-Gastaut syndrome.
Epidiolex contains CBD. The CBD in Epidiolex has been purified. This drug is liquid; it contains sesame oil and strawberry flavor. Studies have shown that Epidiolex helps reduce the frequency of severe seizures in children two years and older with Dravet syndrome and Lennox-Gastaut syndrome. This drug, which is being marketed by Greenwich Biosciences, also increases the cognitive functions of children with epilepsy. Epidiolex is said to be compatible with other medications for epilepsy.
Although Epidiolex is first CBD approved drug to be sold in the United States, it is made from cannabis plants grown in the United Kingdom. The approval of Epidiolex by the FDA came before President Donald Trump signed the 2018 Farm Bill, which permits US farmers to grow hemp.
Until last year, US authorities considered all forms of CBD as Schedule I drugs under the Controlled Substances Act (CSA). Drugs in the Schedule I category are supposed not have medical uses and are prone to be abused. However, following the approval of Epidiolex, the Drug Enforcement Administration (DEA) announced that it had placed Epidiolex in the Schedule V of the CSA, which is a least restrictive schedule.
Following the approval of Epidiolex, the FDA said the organization is committed to promoting scientific studies that reveal how marijuana can be used for medicinal purposes.
“The FDA is committed to advancing scientific research and drug development programs that properly evaluate the active ingredients contained in marijuana,” the Commissioner of the FDA Scott Gottlieb, M.D. said. “Adequate and well-controlled clinical studies supported Epidiolex’s approval, so prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.”
“The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high-quality products,” Gottlieb added.
CBD is slowly becoming as popular as tetrahydrocannabinol (THC). THC is responsible for giving people the feeling of being ‘high.’ CBD does not have any psychoactive effects.
As the debate about the legalization of cannabis goes on, health officials have warned that action will still be taken against the illegal selling of products containing CBD. Authorities will be after products that claim to provide medical benefits without any scientifically approved studies.
According to Gottlieb, ” Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
It is also important to note that Epidiolex has some side effects which include diarrhea, somnolence, vomiting, weight loss, decreased appetite.