The EU has just recently approved the first medicinal-cannabis product for two types of rare but severe childhood epilepsy- Lennox-Gastaut syndrome (LGS) and Dravet syndrome. This drug will soon be available in the UK and Europe after GW Pharmaceuticals, the UK Cambridge-based manufacturer of the product, was given the nod of approval by the European Medicines Agency (EMA) and the European Commission. The drug is called Epidiolex, which is an oral solution of cannabidiol and will be able to be prescribed by doctors if they feel it may help their patients (aged 2 years+) with seizures associated with the two forms of epilepsy. Although it has been approved by the European authorities for use in the UK and Europe, the NHS does not currently recommend the product as ‘the UK's National Institute for Health and Care Excellence made an initial decision not to recommend prescribing Epidiolex, due to lack of evidence of long-term effectiveness. Final guidance is due later this year.’
Epidiolex is an oral, strawberry flavoured drug that is taken twice a day and does not contain any of the psychoactive cannabinoids of the cannabis plant, such as Tetrahydrocannabinol (THC). This drug may help ‘up to 50,000 children and young adults in Europe who have one of the two syndromes, including about 10,000 in the UK.’ GW Pharmaceuticals are still in talks with the UK’s National Institute for Health and Care Excellence (Nice) to try and make the drug available on the NHS. While the first steps are being taken in the UK and Europe, the drug is already available in the US, where approximately 15,000 young patients have been treated. Nice have previously declined Sativex, which is another GW Pharmaceuticals cannabis-based drug for multiple sclerosis, their reasoning for this was due to the high price.
Young patients with LGS or Dravet, suffer from multiple seizures per day and have not responded to other available drugs. These two syndromes also have a high mortality rate in that many patients die before reaching their early 20’s. However, when Epidiolex is used in combination with other anti-epileptic treatments, it has been found that it greatly reduced the number of seizures. Although as with most medicines there can be common side effects, and with Epidiolex these side effects are; sleepiness, decreased appetite, diarrhoea, fever, fatigue and vomiting.
Although this is a major step in the right direction, there are some parents who have travelled to the Netherlands to buy cannabis-medicines for their children, who believe that the new treatment may not help many children due to the absence of THC, which they believe can help.
In the UK, doctors have thus far been cautious to prescribe any cannabis-based medicines due to the lack of clinical trials on its safety and effects. However, the approval of Epidiolex by European authorities may have majorly changed this, and GW Pharmaceuticals continues to conduct clinical trials on Epidiolex to see if it can help patients with other forms of epilepsy.