GW Pharmaceuticals plc today announces the launch in Germany of Sativex® (Delta-9-Tetrahydro-cannabinol and Cannabidiol) oromucosal spray as a treatment of spasticity due to Multiple Sclerosis. This launch follows regulatory approval of Sativex®by the German health authorities in May. Germany has the highest prevalence of MS in Europe.
Sativex® is a first in class endocannabinoid system modulator and is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue). Sativex®offers the first new therapeutic option in decades to patients in Germany who have previously failed to respond adequately to other anti-spasticity medication. The spray is quickly absorbed through the oral mucosa, is easy to use for patients and enables them to optimally adjust their dosage. The medicine is already available for MS patients in the UK and Spain.
Spasticity (otherwise known as muscle stiffness) is a common symptom of MS affecting about 80% of the 130,000 MS patients in Germany. Spasticity has a negative impact on patients' daily lives, affecting their mobility, physical capabilities and thus their overall quality of life.i Spasticity often leads to patients having to modify or give up certain activities and to the need for help from a family member or carer. If not treated adequately, spasticity can have long term effects and complicate treatment of other symptoms.
"Spasticity in multiple sclerosis can have a significant negative impact on patients' daily lives. In particular, muscle cramps and stiffness are usually very painful and can disturb sleep. This new medication is therefore a highly promising treatment option for both neurologists and patients", said Prof. Dr. med. Juergen Koehler, Managing Director and Medical Head of the MS Treatment Center, Kempfenhausen.
Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in MS, while alleviating associated symptoms. The relief of symptoms and positive impact on sleep quality and mobility enables patients to better cope with everyday tasks.
"Almirall's philosophy is to provide innovative solutions for patients. This first new medication for treating spasticity in multiple sclerosis offers an important new treatment option to help multiple sclerosis patients improve their spasticity and associated symptoms", said Farid Taha, Managing Director, Almirall, Germany, Austria and Switzerland.
Sativex® contains active ingredients called 'cannabinoids', which are extracted from cannabis plants grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that occur naturally throughout our bodies, including in our brains.ii A receptor is a site on a brain cell where certain substances can stick or "bind" for a while. If this happens, it has an effect on the cell and the nerve impulses it produces, which causes a 'dimming down' of the symptoms of spasticity. In patients who respond to Sativex®, it is this effect which helps to improve their symptoms of spasticity and to help them cope better with their usual daily activities.iii
In addition to Germany, Almirall also expects to launch Sativex® in Denmark and Sweden before the end of 2011. Launches in Italy, Czech Republic and Austria are expected in 2012.
Sativex® is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Sativex® was developed by GW Pharmaceuticals. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).
i DMSG, www.dmsg.de, (Latest access: 6.05.2011)
ii GW Pharmaceuticals. Cannabinoid Science: Mechanism of action. Available at http://www.gwpharm.com/mechanism-of-action.aspx (Last accessed: 01/05/11).
iii GW Pharmaceuticals. Cannabinoid Science: Cannabinoid Compounds. Available at http://www.gwpharm.com/types-compounds.aspx (Last accessed: 01/05/11).