Two rare forms of epilepsy can now be treated in Spain with the first medicine made exclusively from cannabidiol (CBD) -one of the components of the cannabis plant- has been authorized by the Ministry of Health for patients over two years of age following clinical trials involving 714 people.
What is CBD, the component of cannabis that doesn't get you high but is gaining more and more followers every day?
GW Pharmaceuticals, a global leader in cannabinoid-based medicines and now part of Jazz Pharmaceuticals, presented "Epidyolex" at a press conference this Tuesday, the first drug the company has marketed in Spain. It is indicated, along 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, instability, or diarrhea, common to other medications used to treat this disease and which can be controlled by adjusting the doses.
Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) are two rare forms of epilepsy with high morbidity and mortality rates, and they pose a significant burden to families and caregivers. Many patients with LGS or DS experience multiple seizures each day, placing them at constant risk for falls and injuries.
"Potential improvement in quality of life"
According to neurologist Vicente Villanueva, head of the Refractory Epilepsy Unit at La Fe University and Polytechnic Hospital in Valencia, the trials have shown a reduction in the overall seizure rate in patients with Lennox-Gastaut syndrome (PGT), which means numerous falls are avoided. "As clinicians and researchers, we are pleased to have these new options," explained the researcher, who led the study in patients with Lennox-Gastaut syndrome at La Fe, at the press conference.
Antonio Gil-Nagel Rein, a neurologist and director of the Epilepsy Program at the Rúber International Hospital in Madrid, agrees with this opinion. He noted that "the potential improvement in quality of life in an area where therapeutic options are very limited is good news." "Access to a new drug with a novel and clinically proven mechanism of action is a source of 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 plant's therapeutic potential and believes that patients and their physicians deserve access to innovative, effective, safe, and high-quality cannabis-based medicines. This can only happen, the company emphasizes, if cannabis products undergo rigorous, high-quality clinical trials and approval by health authorities, as is the case with all other medicines.
The general manager of Jazz Pharmaceuticals in Spain and Portugal, Inés Perea, expressed her satisfaction this Tuesday with the approval of this drug and her commitment to continuing to develop cannabis-based products that will change the lives of patients with epilepsy, sleep disorders, or tumors.
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