Cannabis plant (Michael Fischer, Pexels.com)
26 June 2018. A drug based on chemicals derived from cannabis plants was approved by Food and Drug Administration for marketing in the U.S. to treat seizures associated with two rare and severe forms of epilepsy. The drug, marketed as Epidiolex, is made by Greenwich Biosciences in Carlsbad, California, a subsidiary of GW Pharmaceuticals in London.
FDA approved Epidiolex as a treatment for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age or older. Lennox-Gastaut syndrome is a rare, severe form of epilepsy marked by multiple types of seizures and intellectual disability. Seizures often begin in early childhood, and include tonic seizures where muscles stiffen uncontrollably, while other seizures can result in loss of consciousness or weak muscle tone, also known as drop seizures, causing falls and injuries.
Dravet syndrome is also a rare form of epilepsy, marked by frequent or prolonged seizures that begin in the first year but can continue throughout a lifetime. Children with Dravet syndrome typically experience poor development of language and motor skills.
Epidiolex is an oral formulation of cannabidiol or CBD that the company says does not produce an emotional high associated with marijuana, also a derivative of cannabis. FDA based its approval in part on results of three clinical trials showing Epidiolex helped reduce the frequency of seizures among people with Lennox-Gastaut or Dravet syndromes, when taken with other drugs, compared to placebos.
In one of those trials, as reported in Science & Enterprise, results show marked reductions in the number of drop seizures among Epidiolex recipients, with drop seizures diminishing by 42 percent among the high-dose Epidiolex recipients, while those receiving the lower dose experienced a 37 percent reduction. Placebo recipients reported 17 percent fewer drop seizures.
The trial also showed high rates of adverse effects, particularly among high-dose Epidiolex recipients. While most adverse effects were rated mild or moderate, they included sleepiness, vomiting, diarrhea, fever, decreased appetite, and upper respiratory infection. FDA is requiring the makers of Epidiolex to be dispensed with a medication guide outlining the drug’s uses and risks.
In a separate statement, FDA Commissioner Scott Gottlieb, says the agency will continue to consider new drugs based on cannabis if, as in this case, they meet rigorous standards for efficacy and safety. “We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products,” says Gottlieb, “and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.”
Because Epidiolex offers a new type of treatment for rare diseases, FDA gave the drug accelerated review, including Fast Track and Orphan Drug designations that not only speed the review process, but also reduce or eliminate filing fees and provide tax credits for clinical trials. At the same time, the makers of Epidiolex were required to conduct separate studies to evaluate the drug’s abuse potential.
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