GWP.L Regulatory News (GWP)

27 Sep 2005 07:04

GW Pharmaceuticals PLC27 September 2005 Sativex(R), a Cannabis-Based Medicine, Significantly Reduces Central Neuropathic Pain in People with Multiple Sclerosis London, United Kingdom, 27th September 2005: The cannabis based medicine, Sativex(R), is effective in reducing central neuropathic pain and sleepdisturbance in people with Multiple Sclerosis (MS) in a UK study published todayin the medical journal, Neurology.(1) This randomised, controlled trial demonstrates that Sativex was significantlysuperior to placebo in reducing the mean intensity of pain (p=0.005) and sleepdisturbance (p=0.003) amongst people with MS.(1) The study was conducted in 66 patients, 65% of whom required support to walk orwere 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 trial.(1) Sativex was administered as an oromucosal spray allowing flexible dosing whichis ideally suited to the variable nature of MS. Sativex was generally welltolerated in the study.(1) Dr Carolyn Young, principal investigator and Consultant Neurologist based at theWalton Centre for Neurology and Neurosurgery in Liverpool said, "Centralneuropathic pain occurs frequently in people with MS. It can be tremendouslydebilitating and unresponsive to existing therapies. Our findings demonstratethat Sativex was effective in reducing both central pain in MS and pain-relatedsleep disturbance in a population with moderate to severe central paininadequately relieved by existing medication". Sativex has been developed by UK-based GW Pharmaceuticals plc and is currentlyapproved as a prescription medicine in Canada for the symptomatic relief ofneuropathic pain in adults with MS. Sativex is marketed in Canada by BayerHealthCare. An ongoing clinical trial programme is currently being undertaken tosupport regulatory approval in the UK. Upon UK approval, Sativex will beexclusively marketed by Bayer HealthCare. - Ends - GW Pharmaceuticals plc + 44 (0)1980 557 000Dr Geoffrey Guy, ChairmanJustin Gover, Managing DirectorMark Rogerson, Press and PR + 44 (0)7885 638 810 Weber Shandwick Square Mile + 44 (0)20 7067 0700 Kevin Smith/Yvonne Alexander Notes to Editors SativexSativex is derived from whole plant extracts of two specifically bred cannabisplant varieties. The extracts are combined to produce a standardised formulationcontaining two major components of cannabis, the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Sativex is formulated into a pump action oromucosal (mouth) spray designed forself-administration by the patient. Each spray of Sativex delivers a fixed doseof 2.7mg THC and 2.5mg CBD. Central Neuropathic PainNeuropathic pain is caused by damage to or dysfunction of the nervous system. Itis usually chronic and accompanied by unpleasant burning or shooting sensations,or extreme sensitivity to touch. It is estimated that at least 2.4% of the world's population suffers fromneuropathic pain (2), including over 1.4 million patients in UK. It is estimated that central neuropathic pain (pain initiated or caused bydamage to the central nervous system, i.e. brain or spinal cord) occurs in up to52% of people with multiple sclerosis (3). Up to 32% of patients with MS regard pain among their most severe symptoms (4) describing it as frequent, disabling and inadequately managed.(5) About GW Pharmaceuticals plcGW Pharmaceuticals plc is licensed by the UK Home Office to undertake apharmaceutical research and development programme to develop non-smokedcannabis-based prescription medicines. GW's shares are publicly traded on AiM, amarket on the London Stock Exchange. Full details of GW and the company's clinical trials programme can be found atwww.gwpharm.com. GW's clinical research program is being carried out by a teamof pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems. About Bayer HealthCare AGBayer 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 billionEuro. The company combines the global activities of the divisions Animal Health,Biological Products, Consumer Care, Diabetes Care, Diagnostics andPharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004. Bayer HealthCare's aim is to discover and manufacture innovative products thatwill improve human and animal health worldwide. The products enhance well-beingand quality of life by diagnosing, preventing and treating disease. References (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(2) Neuropathy Trust 2005. www.neurocentre.com (Source September 2005)(3) Biovie J. Central Pain. In: Wall PD, Melzack R, eds. Textbook of pain, 4th ed. Hong Kong: Harcourt Publishers Ltd, 1999:879-914(4) Stenager E, Knudsen L, Jensen K. Acute and chronic pain syndromes in multiple sclerosis. Acta Neurol Scand 1991;84:197-200(5) Thompson AJ. Symptomatic treatment in multiple sclerosis. Curr Opin Neurol 1998;11(4):305-309 This information is provided by RNS The company news service from the London Stock Exchange