The First Cannabinoid Prescription Drug Is Approved By The FDA For The Treatment Of Childhood Epilepsy
On June 25th, the US Food and Drug Administration (FDA) issued a prescription for the approval of Epidiolex, a drug consisting of active ingredients extracted from cannabis, for the treatment of rare epilepsy in children over two years of age. According to reports, the drug is the first drug containing cannabis ingredients approved for use in the medical field. Its approval may facilitate the legalization of more illegal cannabis drug research under existing federal regulations.
The drug is produced by GW Pharmaceuticals for the treatment of Lennox-Gastaut syndrome and Draview syndrome. Both of these diseases are rare and difficult to treat in childhood epileptic seizures. The drug was awarded a priority review. The drug is also being reviewed by the European Medicines Agency (EMA) and is expected to be decided in the first quarter of 2019. The FDA Advisory Committee gave positive comments on this earlier this year. Currently, the US FDA has approved the market for the drug.
The FDA Director stated that this approval is not an endorsement of all cannabis products, but also states that it will continue to support rigorous scientific research on the potential medical uses of cannabis derivatives.
According to the Washington Post, the drug called Epidiolex is a high-purity cannabisdiol (CBD) oral solution. Cannabinol (CBD) is an inactive ingredient in high content in cannabis plants. In addition, the drug contains only a trace amount of the psychoactive element THC, which does not cause the user to be emotionally excited. US Food and Drug Administration officials said the drug did reduce seizures in a randomized controlled trial of 500 patients.
Epidiolex is currently only approved for patients 2 years of age and older with two specific syndromes (Lennox-Gastaut, Dravet). These two conditions can cause patients to have uncontrolled epileptic seizures daily and place them at high risk of physical and intellectual disability, injury, and even premature death. At present, the number of people with such diseases in the United States is close to 45,000. Experts predict that the drug can be used to treat other types of epilepsy in the future.