THE FIRST AUTHORIZED MEDICINE MADE WITH CANNABIDIOL ARRIVES IN SPAIN

Two rare forms of epilepsy can now be treated in Spain with the first drug made exclusively from cannabidiol (CBD) -one of the components of the cannabis plant- which has been authorized by the Ministry of Health for patients over two years old after clinical trials in which 714 people participated.

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

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

The most common adverse effects were drowsiness, unsteadiness or diarrhea, which are common to other drugs used to treat this disease and can be controlled by adjusting the doses. 

Lennox-Gastaut (LGS) and Dravet (DS) 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 SLG or DS have multiple seizures each day, placing them at constant risk for falls and injury. 

"Potential improvement in quality of life."

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

Antonio Gil-Nagel Rein, neurologist and director of the Epilepsy Program at the Hospital Rúber Internacional in Madrid, agrees with this opinion and pointed out that "the potential improvement in the quality of life in an area where the therapeutic options are very limited 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," he 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 plant-derived cannabis-based prescription medicine 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 cannabis-based medicines that are effective, safe and of high quality. This can only happen, the company stresses, if cannabis products are subjected to rigorous, high-quality clinical trials and approval by health authorities, just as all other medicines are.

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

Source: 20minutos

100% NATURAL PRODUCTS