In the randomised, double-blind trial, led by Professor Christine Collin from the Royal Berkshire and Battle NHS Trust, Reading, UK, Sativex demonstrated significant superiority to placebo in reducing spasticity (p<0.05) in people with MS. Further, despite having achieved the maximum benefit on existing anti-spasticity medication, four out of every ten of patients achieved more than a 30% further improvement in their spasticity following treatment with Sativex.

The six week study was conducted in 189 MS patients, all of whom were experiencing significant levels of spasticity and had failed to gain adequate relief from currently available anti-spasticity medications. Patients enrolled in the study continued to take their existing medication throughout the trial.

Spasticity is one of the most common symptoms of MS, occurring in up to 84% of people with MS. Spasticity can severely impact quality of life affecting daily activities such as walking and sitting.  It is one of the most difficult symptoms of MS to treat. Professor Christine Collin, principal investigator and Consultant Neurorehabilitation Specialist, commented, "Spasticity can be tremendously debilitating and is notoriously difficult to treat.  Our findings provide encouraging evidence of the effectiveness of Sativex in reducing spasticity even in difficult to treat patients who have failed to gain enough improvement from currently available medication."

Christine Jones, Chief Executive of the MS Trust, said, "Effective relief of spasticity is extremely important to people with MS.  Spasticity and muscle spasms are not only distressing and painful, they can have a negative impact on quality of life. The results of this study add to the growing body of evidence that cannabis-based medicines can be effective in helping to relieve this common symptom of MS."

"Spasticity can make simple daily activities that most people take for granted seem daunting. Just dressing and moving around the home can be difficult and I often have to rely on a carer for support.  With Sativex, I'm able to choose how much I take depending on how bad my symptoms are, which is a real benefit" added Fern Andrews, who has taken part in clinical trials with Sativex.

GW Pharmaceuticals has a broad-based regulatory strategy for Sativex with multiple late stage trials underway for the product in various indications. In addition to the ongoing submission in Europe, Sativex is approved and marketed in Canada for the symptomatic relief of central neuropathic pain in MS, and is the subject of an ongoing regulatory submission in Canada for the relief of cancer pain.  Upon approval of the current MS spasticity submission, Sativex will be marketed in the UK by Bayer Healthcare and in the rest of Europe by Almirall.

On February 14, 2007, GW signed an exclusive license and development agreement to develop and market Sativex® in the United States with Otsuka Pharmaceutical Co., Ltd.  The companies are also in detailed discussions with a view to entering into a cannabinoid research collaboration in the field of Central Nervous System (CNS) disorders and cancer treatment in order to research, develop and commercialize a range of other early stage cannabinoid product opportunities.

GW Pharmaceuticals, 2/28/2007:
http://www.gwpharm.com/news_press_releases.asp?id=/gwp/pressreleases/currentpress/2007-02-28/