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The US FDA approves cannabidiol medicine Epidiolex for use in Lennox-Gastaut syndrome and Dravet syndrome

28 Jun 2018

On Monday 25 June, the US Food and Drug Administration (FDA) approved the new cannabis-based medicine Epidiolex for use in Lennox-Gastuat syndrome (LGS) and Dravet syndrome.

GW Pharmaceuticals’ medicine has been approved for use for the two rare and severe forms of epilepsy in two-year-olds and above. According to reports, it is set to become available in the US in the autumn.

A decision is expected from the European Medicines Agency (EMA) on the use of Epidiolex in the UK and Europe early next year. If approved, the medicine will become available a little later in the year.

The medicine is made from a part of the cannabis plant called cannabidiol (CBD). This does not contain the part of the cannabis plant that creates a ‘high’.

CBD has recently undergone a number of clinical trials to assess its effectiveness and safety when treating LGS and Dravet syndrome. It has been shown to have beneficial effects in treating both of these forms of epilepsy.

The FDA said the most common side-effects from the Epidiolex clinical trials included sleepiness, loss of appetite and diarrhoea. People also sometimes experienced a rash, weakness, poor quality sleep, infections and an impact on the liver.

FDA commissioner Dr Scott Gottlieb said that thorough clinical trials and careful review is the most appropriate way to bring cannabis-based treatments to people.

Dr Billy Dunn, director of the Division of Neurology Products at the FDA said that the seizures in people with Drave syndrome or LGS have “a profound impact on these patients’ quality of life”.

Reports say this is the first ever medicine approved specifically for treating Dravet syndrome.

There is more information on the rare epilepsy syndromes on the Epilepsy Action website. You can also find on the website Epilepsy Action’s position statements on cannabis-based medicines.


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