(Gerd Altmann, Pixabay)
24 Sept. 2019. The European Commission yesterday endorsed a recommendation to market in Europe a cannabis-based treatment for seizures from two rare forms of epilepsy. The EC’s decision clears the way for physicians in Europe to prescribe the drug Epidyolex, made by Greenwich Biosciences Inc., a subsidiary of GW Pharmaceuticals in London and Carlsbad, California, to treat patients with seizures from Lennox-Gastaut syndrome and Dravet syndrome.
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.
Epidyolex is the brand name in Europe for Greenwich’s oral formulation of cannabidiol or CBD that the company says does not produce an emotional high associated with marijuana, also a derivative of cannabis. The drug reduces hyperactivity of neurons by limiting chemical stimuli and signals associated with seizures. While CBD is derived from cannabis, it does not contain tetrahydrocannabinol or THC, the psychoactive component of marijuana causing intoxication.
GW Pharmaceuticals says Epidyolex was tested in four late-stage clinical trials among 714 patients with Lennox-Gastaut or Dravet syndrome. The most common side effects are sleepiness, fatigue, loss of appetite, diarrhea, fever, and vomiting.
In July, the European Medicines Agency accepted the recommendation of its review committee to authorize marketing of Epidyolex. The committee recommended Epidyolex as a supplemental treatment for Lennox-Gastaut syndrome and Dravet syndrome along with the epilepsy drug Clobazam for patients age 2 years or more. The EC’s endorsement of that decision applies to all 28 countries of the European Union, as well as Norway, Iceland, and Liechtenstein..
In June 2018, as reported by Science & Enterprise, the Food and Drug Administration approved the same drug, but with the brand-name Epidiolex, for U.S. distribution to treat Lennox-Gastaut and Dravet syndromes. FDA approved the drug as a first-line therapy, not a supplemental treatment.
“The approval of Epidyolex marks a significant milestone,” says Justin Gover, CEO of GW Pharmaceuticals in a company statement, “offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy.”
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