The first authorized drug made with cannabidiol arrives in Spain

Of the rare forms of epilepsy can already be treated in Spain with the first drug made exclusively based on cannabidiol (CBD) -one of the components of the cannabis plant- which has been authorized by the Ministry of Health for patients for more than two years after clinical trials in which 714 people have participated.

The GW Pharmaceuticals laboratory, a world leader in cannabinoid-based drugs and now part of Jazz Pharmaceuticals, presented this Tuesday at a press conference “Epidyolex”, the first drug that this company markets in Spain. It is indicated, together with clobazam, for the treatment of seizures associated with Lennox-Gastault syndrome (LGS) and Dravet syndrome (DS), and will be dispensed in a hospital pharmacy.

Your approval is based on the results of four phase III trials placebo-controlled and randomized, with data from more than 714 patients in which this drug produced improvements.

The Adverse effects most common were drowsiness, instability or diarrhea common to other medications to treat this disease and that can be controlled by adjusting the doses.

Lennox-Gastaut (SLG) and Dravet (SD) syndromes are two rare forms of epilepsy with high morbidity and mortality rates, and place a significant burden on families and caregivers. Many patients with LGS or DS have multiple seizures each day, placing them at constant risk for falls and injuries.

“Potential improvement of the quality of life”

As explained this Tuesday by the neurologist Vicente Villanueva, Head of the Refractory Epilepsy Unit of the Hospital Universtiari i Politècnic La Fe de València, the trials have confirmed in patients with Lennox-Gastaut syndrome a 40% reduction of the global crisis, which means avoiding numerous falls. “As clinicians and researchers we are satisfied to have these new options”, explained at the press conference this researcher who led the study in patients with Lennox-Gastaut syndrome in La Fe.

Agrees on the opinion Antonio Gil-Nagel Rein, neurologist and director of the Epilepsy Program at the Rúber Internacional Hospital in Madrid, who has stated that “the potential improvement in 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“, Has celebrated.

Approved in 2019

“Epidyolex” is an oral solution containing highly purified cannabidiol (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 authorization.

The approval of cannabidiol oral solution was based on the results of four randomized controlled phase III trials. Spain has participated in the clinical development of this therapy with more than 10 hospitals. Over the past two decades, GW has conducted scientific research and clinical trials to discover the therapeutic potential of the plant and believes that patients and their physicians deserve access to innovative drugs based on cannabis that are effective, safe and of quality. This can only happen, they point out in the company, if cannabis products undergo rigorous high-quality clinical trials and approval from health authorities, as is done with the rest of the medicines.

The general director of Jazz Pharmaceuticals in Spain and Portugal, Inés Perea, this Tuesday expressed her satisfaction with the approval of this drug and her commitment to continue developing cannabis-based products that change the lives of patients with epilepsy or sleep disorders or tumors.

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