Multiple Sclerosis (MS) affects more than 1.2 million people worldwide, including an estimated 100,000 people in the UK and 500,000 people across Europe. It is the most common neurological disease among young adults. MS affects twice as many women as men and typically develops between the ages of 20-40 years. People with MS have virtually a normal life expectancy.
People with MS suffer from a range of symptoms, including pain, muscle spasticity and spasm, bladder problems and sleep disturbance.
There is a very clear need for new treatments for MS symptoms. According to the MS Society, “There are few effective treatments for the symptoms of MS. Most of the current drugs only benefit a minority of people and frequently have adverse side effects… this is especially true of pain control, where few treatments are effective… Available treatments for spasticity… afford partial relief and have unpleasant side effects.”
Patients with MS have long reported that cannabis alleviates their symptoms. Some surveys show that over one third of MS patients in the UK may be using cannabis illegally at present for its medical benefits. The MS Society recognise the significant potential benefits of having a standardised approved prescription cannabinoid medicine:
“If cannabinoid-based medicines can safely provide relief from any symptom of MS, they will not only improve the quality of life of people with the condition but also the people who care for them. The benefits of a drug that can restore some aspect of normal work and social life cannot be overestimated.”
For more information from the MS Society,click here.
The Sativex clinical development programme has focused primarily on the symptoms of spasticity (spasms and stiffness) and pain. Spasticity is one of the most common symptoms of MS occurring in as many as three-quarters of people with MS. Spasticity can affect many aspects of daily life, such as walking and sitting. Pain is also a common symptom of MS occurring in up to 86 per cent of people with MS.iNeuropathic or nerve pain can occur spontaneously or can be provoked by touch, temperature or movement. It is estimated that 50 per cent of people with MS suffer from chronic neuropathic pain.ii, iii, ivMany individuals with neuropathic pain respond inadequately to current treatment options.v, viAs well as spasticity and pain, Sativex has also been shown to relieve bladder disfuntion.vii Ninety per cent of people with multiple sclerosis (MS) develop lower urinary tract symptoms after 10 years of disease activity.
Sativex is approved and marketed in the UK and Spain for the relief of spasticity in MS.
In additional European countries, Sativex has successfully completed the European Mutual Recognition Procedure (MRP) with the regulatory authorities in six member states (Germany, Italy, Denmark, Sweden, Austria and the Czech Republic) confirming that Sativex meets their requirements for approval. The next step in the regulatory process involves separate national phases in each country to finalise local wording on product packaging and related documents and also to agree any other country-specific requirements. Following completion of the national step, we expect each country to then issue a national marketing authorisation. We anticipate launch before the end of 2011 in Germany, Denmark and Sweden with the remaining countries expected in 2012.
Sativex is approved in New Zealand and Canada for the treatment of spasticity due to Multiple Sclerosis and also approved and marketed in Canada for the relief of neuropathic pain in MS and cancer pain.