Phase III Sativex(R) Data Published in Leading Neurology Journal
- Category: Small Molecules
- Published on Thursday, 01 March 2007 02:00
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PORTIN DOWN, UK | Feb 28, 2007 | A leading neurology journal, The European Journal of Neurology, today reports a study showing that Sativex significantly reduces intractable spasticity (spasms and stiffness) in people with Multiple Sclerosis (MS).
The publication of these data follows the previous announcement of preliminary results of this 189 patient study, which forms part of the regulatory filing for Sativex for MS spasticity submitted in September 2006 in selected European countries.
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 MS1. 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 trial1.
Spasticity is one of the most common symptoms of MS, occurring in up to 84% of people with MS1. 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 treat1.
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 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 14 February 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.
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Notes to Editors
Sativex® (THC:CBD), an endocannabinoid system modulator, is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids D9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Sativex® is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient. This formulation allows for flexible dosing, ideal for the variable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated in the study.
Spasticity results from more than one group of muscles contracting incorrectly, causing spasms or stiffness. Spasms are uncontrollable muscle contractions and can be painful. They can be a particular problem at night causing disruption of sleep. Limbs may shoot away or bend upwards towards the body and severe spasms may make the back arch off the bed or chair.
Stiffness of the limbs is common and can make it difficult to perform normal activities, particularly delicate movements of the hand and fingers. If the leg muscles are affected it can make walking difficult. Current treatments are often only partially helpful.
GW Pharmaceuticals plc
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products that alleviate pain and other neurological symptoms in patients who suffer from serious ailments.
GW has assembled a team of over 100 scientists with extensive experience in developing 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
1. Collin C, Davies P, Mutiboko IK, Ratcliffe S, for the Sativex Spasticity in MS Study Group. Randomised controlled trial of cannabis based medicine in spasticity caused by Multiple Sclerosis. European Journal of Neurology (2007) 14 (3), 290–296
SOURCE: GW Pharmaceutical