Cannabis Medicinal Use
Sativex® approved in Denmark for the treatment of spasticity due to Multiple Sclerosis (MS)
The Danish Interior and Health Minister approves Sativex®, the first cannabis-based medicine in Denmark
Launch of Sativex® in Denmark is expected later this month
Barcelona, Spain and Porton Down, UK; 8th June 2011: Almirall, S.A. (ALM:MC) and GW Pharmaceuticals plc (AIM:GWP) today announced that the health authorities in Denmark have granted regulatory approval for Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to MS in patients who have not responded adequately to other anti-spasticity medication.
Regulatory approval for Sativex® has been grantedafter the recent change in the local laws. Sativex® is a first in class endocannabinoid system modulator for the treatment of spasticity in MS, currently available in the UK and Spain.
Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder or sleep disturbance. By relieving the symptoms of MS, Sativex® can improve patients' quality of life and allow them greater independence in performing their daily activities.
Approval in Denmark follows successful completion in March 2011 of the European Mutual Recognition Procedure (MRP) with all countries involved recommending approval. Approval for Sativex® was granted in Germany on 26th May 2011 and the product is expected to be launched there in July. In addition to Germany and Denmark, launch is also expected in Sweden before the end of 2011. Launches in Italy, Czech Republic and Austria are expected in 2012.
A further MRP is planned for later 2011 involving other European countries, in order to make this medicine available to more patients suffering from MS.
Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).
What is Sativex®
Sativex® is an endocannabinoid modulator made of two actives - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) - which was developed and is manufactured by GW.
Sativex® is indicated as an add-on treatment for patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not adequately responded to other anti-spasticity medications and who have demonstrated a clinically significant improvement in symptoms related to spasticity during an initial treatment testing period.
Sativex® contains active ingredients known as 'cannabinoids' which are extracted from the plant Cannabis Sativa grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that exist naturally throughout our body, including the brain. A receptor is a site located in a brain cell in which certain substances can stick or "bind" for a while. If this happens, this binding has an effect on the cell and the nerve impulses it produces, causing a 'dimming-down' of the spasticity symptom. In patients who respond to Sativex®, this is the effect that improves their spasticity symptoms and helps them cope with their daily activities.
Sativex® is approved in the UK, Spain, Canada and New Zealand in the treatment of spasticity due to MS. In addition, a further six European countries (Germany, Italy, Sweden, Denmark, Austria and the Czech Republic) have recently recommended Sativex® for approval and are expected to grant national licences in mid-2011.
There are almost 500,000 people suffering of MS in the top five EU countries, and 10,000 of them are reported to live with the condition in Denmark. Spasticity (otherwise known as muscle stiffness) is one of the most common symptoms of MS, occurring in as many as 75% of people with MS and has a negative impact on patients' daily lives as it reduces their capacity to carry out everyday activities such as walking, keeping upright, as well as having an impact on their general mobility, bladder function, and quality of sleep. This means patients have to modify or give up certain activities and often require help from a family member or carer. About half of people with MS do not manage to find relief from these symptoms with currently available treatments.
Sativex® recently commenced a Phase III trials programme in cancer pain, which is being performed in conjunction with GW's licensing partner for Sativex® in the US, Otsuka Pharmaceutical Co. Ltd. The programme includes two Phase III randomised placebo-controlled multi-centre multinational trials as well as a long term extension study. Each Phase III trial will include approximately 370 patients and will evaluate the efficacy and safety of Sativex versus placebo over a 5 week treatment period.
Studies suggest that more than one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain. Large surveys indicate that optimal opioid therapy does not yield sufficient relief in a substantial proportion of these patients.
About GW Pharmaceuticals
GW Pharmaceuticals plc (AIM:GWP) was founded in 1998 and is listed on the AIM, a market of the London Stock Exchange. Operating under licence from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular MS and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.
For further information, please visit www.gwpharm.com
GW Pharmaceuticals: Cannabinoid Science: Mechanism of action. Available at. http://www.gwpharm.com/mechanism-of-action.aspx
GW Pharmaceuticals: Cannabinoid Science: Cannabinoid Compounds. Available at http://www.gwpharm.com/types-compounds.aspx.
Rizzo MA et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004;10:589-595.
Multiple Sclerosis Trust. A-Z of MS - Spasticity. Available at: http://www.mstrust.org.uk/atoz/spasticity.jsp .
2010 EMSP, MSIF, www.europeanmapofms.org, 16/06/2010. Top five EU countries include: France, Germany, Italy, Spain and UK.