Spain approves first cannabis-based medicine

16th September 2021

The first cannabis-based medicine has arrived in Spain in order to treat those who suffer from some of the most severe medical conditions, such as treatment-resistant epilepsy.

According to 20 Minutos, Epidyolex, an oral solution containing highly purified cannabidiol (CBD), has been approved in Spain by the Ministry of Health after a two-year trial that involved more than 700 participants.

The approval of this cannabidiol oral medicine was based on the results of four randomised controlled Phase III trials. Spain has participated in the clinical development of this therapy with more than 10 hospitals.

The life-changing medicine and clobazam, the drug that can be used for the treatment of seizures associated with Lennox-Gastault syndrome (LGS) and Dravet syndrome (DS), will be available from hospital pharmacies.

Antonio Gil-Nagel Rein, a neurologist, and director of the Epilepsy Program at the Ruber International Hospital said: “The potential improvement of the quality of life in an area where the therapeutic options are very small, is good news.

“Access to a new drug with a novel and clinically proven mechanism of action is a reason for hope for patients and satisfaction for specialists.”

In September 2019, Epidyolex received approval from the European Commission, making it the first cannabis-based prescription medicine derived from plants to receive this authorisation.

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