First Cannabis-Based Drug to Treat Epilepsy Approved, Called Epidiolex

Epidiolex, the first cannabis-based drug authorized for the treatment of epilepsy, has also received the green light in Europe. This is a milestone that could lead to CBD being considered a pharmacological principle and to the diffusion of this drug also in Italy to treat forms of epilepsy that do not respond to traditional treatments, especially in children.

Epidiolex, the first drug in the world based only on CBD has also been approved in Europe. Not only that: it is also the first drug based on a cannabis derivative that has been approved for the treatment of epilepsy, especially in forms resistant to traditional drugs and in pediatrics.

This means that from now on it will also be prescribable in Italy, alongside the inflorescences with a high CBD content and the extracts that can be obtained from them that were already dispensed experimentally to dozens of children at the Gaslini hospital in Genoa.

“Therapeutic cannabis has changed our lives because by improving Matteo’s health and his serenity, it has changed the daily life of our family,” Barbara Bagnale told us, speaking of her son Matteo, one of over 20 children then being treated at Gaslini, where young patients suffering from various forms of refractory epilepsy significantly improve their health conditions thanks to cannabis. “We went from 98 epileptic seizures recorded in hospital in 24 hours, to 2 or 3 small spasms, and not seizures, during the day,” she explained, confirming the primary effect of this drug: that of significantly reducing the number and severity of epileptic seizures, guaranteeing a new life for this family.

A fact that has been confirmed by several scientific studies. The latest of which is a long-term study conducted on 366 patients who were followed for at least 38 weeks. According to the results published in Epilepsia, “The average reduction in the frequency of epileptic seizures ranged from 48% to 60%” and also: “88% of patients reported an improvement in their general condition according to the Global Impression of Change scale”. In the scientific studies conducted, the most common adverse reactions that occurred in patients treated with the drug were drowsiness, decreased appetite, diarrhea, pyrexia, fatigue and vomiting.

“The authorisation of an oral cannabidiol solution is an important milestone for patients and families whose lives are significantly affected by these rare, complex and lifelong forms of epilepsy,” said Isabella Brambilla, President of the European Dravet Syndrome Federation and Associazione Dravet Italia Onlus: “It gives us great satisfaction to know that patients will now have access to a long-awaited new treatment option that has undergone a rigorous programme of clinical trials and has EMA authorisation.”

The European Commission (EC) has in fact authorized the marketing of the drug for use as an adjunctive therapy for epileptic seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in association with clobazam in patients aged 2 years and older. It is an oral drug in liquid form, which can be administered as a syrup.

One concern concerns the sale price, which will be defined at a national and not European level and therefore in Italy it will depend on AIFA, with the possibility, but not the certainty, that it can be prescribed at the expense of the national health system. In the USA, where it was approved in 2018, CNN had pointed out that it could cost patients up to 32,500 dollars a year, while GW Pharmaceuticals, the company that produces it, had pointed out that the cost was in line with traditional treatments currently in use for these pathologies.

Not only that, because this approval marks a milestone in considering CBD as a pharmacological principle. It remains to be seen whether the European Union will choose to consider CBD in general in this sense, thus putting an end to free sale, or whether, as predicted by several experts, concentration thresholds will be established below which (usually 10% is assumed) the product can be sold freely, perhaps classified as a supplement.