Almirall has presented new clinical evidences of Sativex, the only medicine derived from cannabinoids to treat spasticity symptoms in MS, at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Barcelona.
The European trials studied the effectiveness, safety and tolerability of the treatment in patients with spasticity symptoms in Multiple Sclerosis
Sativex is the first prescription medicine based on cannabinoids, active ingredients tetrahydrocannabinol (THC) and cannabidiol (CBD) extracted from the Cannabis sativa plant, an add-on therapy indicated to treat symptoms of moderate or severe spasticity in people with multiple sclerosis who are not responding to other antispastic treatments.
The study tested a population of 1,534 Italian patients with MS. A high initial response rate was observed, with more than 60% of patients continuing treatment after the first-month trial period once proving enough effect (>20% spasticity improvement from baseline) and acceptable tolerability.
About 25% of these patients already showed NRS (Numeric Rating Scale) improvement over 30%. The trial also showed a clinically-relevant effectiveness rate after six months, when 40.2% of them reached NRS improvements over 30% at six months.
The effect of THC:CBD spray on MS spasticity directly recording the stretch reflex after one month of treatment was also tested, and Sativex treatment led to a significant reduction (56%) of the stretch reflex during the therapy.
Multiple Sclerosis (MS) is a chronic nervous system disease which affects more than 2 million patients worldwide. Almost 600,000 European patients with MS suffer from spasticity, one of the most common MS symptoms causing stiffness, involuntary muscle spasms and other associated symptoms, and resulting in a high impact in their quality of life.
From the about 80% of MS patients suffering from spasticity, in a third of them it is moderate to severe, despite classic treatment options. Although many medical and health resources are expended on the medical care of these patients, including treatments and the rehabilitation they need, only half of them receive specific spasticity drug therapy.
Professor Maria Trojano, Professor of Neurology and head of the Department of Basic Medical Sciences Neuroscience and Sensory Organs at the University of Bari in Italy, says: “Large Sativex studies presented today show new supportive evidence in clinical practice on the effectiveness and tolerability of Sativex as the first cannabinoid based treatment for resistant spasticity in all types of MS.
“Sativex inhibits the anomalous nerve impulses that cause rigidity and muscle spasms providing effective relief in spasticity and associated symptoms with an acceptable tolerability profile. Patients can experience improvement in their MS Spasticity related symptoms in a safe way and thereby benefit from an increased quality of life.”
Spanish Professor Rafael Maldonado, director of the Neuropharmacology Laboratory, University Pompeu Fabra, in Barcelona, pointed out the clear distinction between cannabinoid-based medicines and recreational cannabis use.
He says: “The basic most common component of modern herbal cannabis is TCH, which causes psychoactive effects, known as ‘high’, and important tolerability issues, including abuse and addiction risks.
“It is important to remark on the difference between Sativex and herbal cannabis: Sativex is a unique cannabinoid based medicine, which has followed the appropriate R&D and regulatory processes so it is an approved prescription drug supported by proper pre-clinical and clinical studies results. In contrast, recreational cannabis, with over 60 different cannabinoids in it, lacks standardization: the concentration of each cannabinoid is unpredictable and its use has relevant risks and legal implications.
Professor Maldonado adds: “The main barriers to use herbal cannabis as a medicine are its relevant psychoactive effects. In the case of Sativex, the product is well characterised and the selected two active principles (THC and CBD) are present in very constant and balanced amounts after controlled pharmaceutical production. This makes the drug safe and minimises the possible side effect such as the risk of addiction or psychotropic effects.”