Interest has been increasing regarding the use of cannabis to treat two specific forms of epilepsy – Dravet and Lennox-Gastaut Syndromes which will be described below. CBD extracted from the cannabis plant has been used as an effective treatment option for both. It does not contain THC, the active component that gives consumers the “high” or psychoactive effects.
Dravet Syndrome is a rare, severe form of intractable epilepsy that typically presents during the first year of life. (Intractable means the seizures are not controlled by the usual medications.) Early signs of Dravet Syndrome are unique, with the onset of recurrent, convulsive seizures which are often prolonged and may be triggered by a fever. The infant is otherwise developmentally normal and has normal brain MRI and EEG (electroencephalogram) findings.
Lennox-Gastaut Syndrome also begins in early childhood, usually between ages three and five. The seizure type is known as tonic seizures, which cause the muscles to stiffen (contract) uncontrollably.
An Early Success
Stanley Brothers, a Colorado-based company, introduced CBD extract as a treatment option for Charlotte Figi, a five-year-old girl with Dravet Syndrome. Her parents and physicians say she experienced a reduction of seizure activity after her first dose. Charlotte became known as the girl who has changed medical cannabis laws across America, and her treatment became known as Charlotte’s Web. Her successful treatment was featured in the 2013 CNN documentary “Weed”. Media attention that followed helped to increase the demand for Charlotte’s Web and similar products which have been used to treat epilepsy in children. This high CBD product was originally called “Hippies’ Disappointment” because it did not produce the “high” that consumers wanted. It is this author’s opinion that without Charlotte’s experience, the Stanley Brothers’ research, and the media attention they received, we would have seen far less progress in developing treatment. Both parties helped to advance research to treat both Dravet and Lenox-Gastaut Syndromes. New scientific research provides evidence that cannabis may be an effective treatment for one-third of epilepsy patients who have a treatment-resistant form of the disease.
Not all medical cannabis is created equally, so it’s difficult to know what you’re getting. Pharmaceutical-grade CBD is a purified, highly concentrated formulation that is manufactured under strict safety standards. However, there are strains of medical cannabis with inconsistent levels of various compounds which makes it difficult for the cannabis industry to claim medical benefits. Strict testing and manufacturing requirements are necessary to make a compound a reliable source of medication and therefore a successful treatment option.
Support from Professional Organizations
Both the Epilepsy Foundation and the American Epilepsy Society are doing their part to dispel myths and misinformation through public education. They support scientific and pharmaceutical research geared toward standardized dosages to improve healthcare outcomes. In May 2018, the American Epilepsy Society issued a statement saying, “There is recent rigorous research that suggests that the oral version of CBD, a highly formulated pharmaceutical-grade medication, is effective, particularly in some children with Lennox-Gastaut Syndrome and Dravet Syndrome, two treatment-resistant forms of epilepsy. An FDA advisory committee recently unanimously recommended CBD medication be approved for treatment of the two syndromes.” It is important to note that recent research has found CBD medication can be associated with drug interactions, meaning it can negatively interact with other medications, including anti-epileptic drugs.
Research and Regulatory Advancement
In June 2018, the Food and Drug Administration (FDA) accepted the advisory committee’s recommendation and gave approval for Epidiolex for the treatment of seizures associated with Dravet and Lennox-Gastaut Syndromes. It is the first FDA-approved drug that contains a purified substance derived from cannabis, as well as being the first drug approved for the treatment of forms of epilepsy that have previously been difficult to manage.
FDA Commissioner Scott Gottlieb, MD, commented, “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in cannabis can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development.”
In August 2019, MedPharm Research, a Colorado company, received approval from the Drug Enforcement Administration (DEA) to move forward with its application for a license to grow federally legal cannabis and become more active in medical cannabis research. Their press release says, in part, “The goal of MedPharm is to provide a reliable clinical effect through the use of well-crafted and well-researched oil analytics and dosage forms. The company provides cannabis pharmaceutical-type products using Good Manufacturing Practices (GMP) that include pre-formulation, formulation development, small scale commercial manufacturing, analytical method development and validation, routine quality control analysis and stability studies. MedPharm works to create pharmaceutical dosage forms and produce ingredients utilizing pharmaceutical technology to be used in the delivery of cannabis extracts.”
There is a need for the FDA, reputable researchers, and cannabis experts to work together to find treatments that will contribute to positive healthcare outcomes. The combined expertise of established accredited scientific institutions and cannabis experts can contribute to improving disease and symptom management in our society. A win-win for all.