Cannabis Based SATIVEX(R) Significantly Reduces Central Neuropathic Pain in People With Multiple Sclerosis
This randomised, controlled trial demonstrates that Sativex(R) 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(R) was administered as an oromucosal spray allowing flexible dosing which is ideally suited to the variable nature of MS. Sativex(R) was generally well tolerated in the study, although more patients on Sativex(R) than placebo reported dizziness, dry mouth and somnolence. Cognitive side effects were limited to long-term memory storage1.
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(R) has been developed by UK-based GW Pharmaceuticals plc. Sativex(R) is indicated as adjunctive treatment for the symptomatic relief of neuropathic pain in adults with MS. Health Canada has approved Sativex(R) with conditions, under the Notice of Compliance with Conditions (NOC/c) policy. This authorization reflects the promising nature of the clinical evidence which will be confirmed with further studies. Products approved under Health Canada's NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use. Sativex(R) is marketed in Canada by Bayer HealthCare.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
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.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group Management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
About GW Pharmaceuticals plc
GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. GW's shares are publicly traded on AiM, a market on the London Stock Exchange.
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.
This news release may contain forward-looking statements that reflect GW's current expectations regarding future events, including the clinical development and regulatory clearance of its products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and GW's other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.
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1. D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005;65:812
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