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27/09/2005 London, United Kingdom, 27th September 2005: The cannabis based medicine, Sativex®, is effective in reducing central neuropathic pain and sleep disturbance in people with Multiple Sclerosis (MS) in a UK study published today in the medical journal, Neurology1. This randomised, controlled trial demonstrates that Sativex was significantly superior to placebo in reducing the mean intensity of pain (p=0.005) and sleep disturbance (p=0.003) amongst people with MS1. The study was conducted in 66 patients, 65% of whom required support to walk or were wheelchair bound and were suffering from moderate to severe central neuropathic pain which had not been alleviated by currently available medications. Patients continued to take their existing medication throughout the trial1. Sativex was administered as an oromucosal spray allowing flexible dosing which is ideally suited to the variable nature of MS. Sativex was generally well tolerated in the study1. Dr Carolyn Young, principal investigator and Consultant Neurologist based at the Walton Centre for Neurology and Neurosurgery in Liverpool said, "Central neuropathic pain occurs frequently in people with MS. It can be tremendously debilitating and unresponsive to existing therapies. Our findings demonstrate that Sativex was effective in reducing both central pain in MS and pain-related sleep disturbance in a population with moderate to severe central pain inadequately relieved by existing medication". Sativex has been developed by UK-based GW Pharmaceuticals plc and is currently approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is marketed in Canada by Bayer HealthCare. An ongoing clinical trial programme is currently being undertaken to support regulatory approval in the UK. Upon UK approval, Sativex will be exclusively marketed by Bayer HealthCare. - Ends -
Notes to Editors Sativex Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Central Neuropathic Pain It is estimated that at least 2.4% of the world’s population suffers from neuropathic pain2, including over 1.4 million patients in UK. It is estimated that central neuropathic pain (pain initiated or caused by damage to the central nervous system, i.e.brain or spinal cord) occurs in up to 52% of people with multiple sclerosis3. Up to 32% of patients with MS regard pain among their most severe symptoms4 describing it as frequent, disabling and inadequately managed5. About GW Pharmaceuticals plc Full details of GW and the company’s clinical trials programme can be found at www.gwpharm.com. GW’s clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems. About Bayer HealthCare AG The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004. Bayer HealthCare’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
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