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ARCHIVED - First cannabis-based medicine arrives in Spain

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The pioneering drug will be used in treatment-resistant epilepsy patients in Spain

<span style='color:#780948'>ARCHIVED</span> - First cannabis-based medicine arrives in Spain

In a ground-breaking move in Spain, the first drug exclusively based on cannabidiol (CBD), a chemical substance extracted from cannabis, has been legally approved and is now available for sale. The medication, which will only be dispensed through hospital pharmacies, will be used in the treatment of epileptic seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in patients from two years of age.

Epidyolex (the cannabis-based drug’s commercial name) is an oral solution that contains highly purified cannabidiol, or CBD. In September 2019, it received approval from the European Commission, making it the first cannabis-based prescription medicine derived from plants to receive this authorisation. The approval of cannabidiol oral solution was based on the results of four randomised controlled trials with data from more than 714 patients with both epileptic conditions. More than ten hospitals in Spain participated in the clinical development of the medication.

Antonio Gil-Nagel Rein, neurologist and director of the Epilepsy Program at the Ruber International Hospital in Madrid, has welcomed the news, adding that until now, the treatment options for both forms of epilepsy were very limited. The new drugs, he said, will contribute greatly to the quality of life of patients.

Lennox-Gastaut (LGS) and Dravet (SD) syndromes are two rare forms of epilepsy with high rates of mortality. Many patients with LGS or DS have multiple seizures each day, placing them at constant risk of falls and injuries. Despite current treatment with antiepileptic drugs, these two severe forms of epilepsy are highly resistant to traditional treatments.

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