The Dravet syndrome (DS) and the Lennox-Gustaut syndrome (LGS) are two rare diseases affecting the central nervous system and described as serious epileptic encephalopathies, characterised by different kinds of epilepsy attacks, and cognitive and behavioural disorders. Both syndromes arise during childhood: DS begins during the first year of life of an infant, while LGS starts between ages 3 and 5. In spite of existing treatment alternatives, almost 100% of all DS patients experience uncontrolled seizures during childhood.
For this reason, experts agree that Spain has a strong need for safe and provenly efficient therapeutic alternatives for DS patients—children and adults—to curb seizures and comorbidities.
CBD-Based Medications vs Epileptic Crisis
This year, patients and their families celebrate the authorisation of a new treatment to handle epileptic episodes. GW Pharmaceuticals, a world-leading company in the CBD-based medication market and now a part of Jazz Pharmaceuticals, released “Epidyolex”—the first drug to be sold by this company in Spain—on September 14th at a press conference.
This drug was then approved by the Spanish Health Ministry after 714 people took part in clinical trials conducted by La Fe University at Valencia. This authorisation is based on the outcome of four phase III, placebo-controlled, randomised studies, where patients showed improvement after taking the medicine.
The Winners: Patients’ Family and Carers
This is undoubtedly wonderful news for families, because these two syndromes represent a great burden on patients’ close family and friends and their carers—on a physical and an emotional level (including sleep disorders, chronic fatigue, and physical pain from carrying the patient) and also from a financial point of view, given the high prices of drugs. At a press conference, neurologist Vicente Villanueva, Head of the Refractory Epilepsy Unit at La Fe Hospital in Valencia, stressed that epilepsy episodes dropped 40% across all patients with Lennox-Gastaut syndrome who took part in the clinical trials, which implies a great improvement in many cases.
Up to that point, the only legal cannabis-based medication in Spain was Nabiximols (or Sativex), an analgesic for pain caused by multiple sclerosis. According to the Spanish Observatory on Medical Cannabis, the number of medical cannabis users in Spain ranges from 50,000 to 100,000. Mortality rate for people with epilepsy is 2 to 3 times higher than the population at large—33,000 deaths from epilepsy are estimated to occur in Europe every year, out of which 13,000 could be prevented.
“Epidyolex” is an oral solution containing high purity cannabidiol (or CBD). In September 2019, this medication was approved by the European Commission, becoming the first plant-derived, cannabis-based prescription medicine to be granted this kind of authorisation.
20 Years of Research
During the last two decades, GW Pharmaceuticals has carried out extensive scientific research and clinical trials to unlock the therapeutic potential of cannabis. From these data, this company is convinced of the potential therapeutic benefits associated to this plant and firmly believes that patients and doctors deserve access to efficient, safe, and high-quality cannabis-based medications.
This British pharmaceutics company firmly believes that this can only be achieved through research and conducting thorough, high-quality clinical trials and receiving approval from health governing bodies, as is the case with any other kind of drug.
Inés Perea, general manager at Jazz Pharmaceuticals for Spain and Portugal, has claimed that although “there are many strong, conflicting opinions on cannabis (…), there is still a long road ahead, and we are aware of that. We also believe that patients have a right to access this kind of medications.”
“Those cannabis-based products that are still pending approval under applicable regulations may represent several unknown risks for patients and doctors because they are almost completely based on limited scientific evidence,” stated Ángel Ayuga, medical director of Epilepsy at Jazz Pharmaceuticals in Spain.