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, Neurology
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.
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GW Pharmaceuticals pl: (12/12/05) + 44 20 7067 0700
Dr Geoffrey Guy, Executive Chairman: (Thereafter) + 44 1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR + 44 7885 638810
Weber Shandwick SquareMile: + 44 20 7067 0700
Notes to Editors
Sativex 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 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
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
Neuropathic pain is caused by damage to or dysfunction of the nervous system. It is 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 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 symptoms4describing it as frequent, disabling and inadequately managed5.
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.
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
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.
- 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
- Neuropathy Trust 2005.www.neurocentre.com(Source September 2005)
- Biovie J. Central Pain. In: Wall PD, Melzack R, eds. Textbook of pain, 4th ed. Hong Kong: Harcourt Publishers Ltd, 1999:879-914
- Stenager E, Knudsen L, Jensen K. Acute and chronic pain syndromes in multiple sclerosis. Acta Neurol Scand 1991;84:197-200
- Thompson AJ. Symptomatic treatment in multiple sclerosis. Curr Opin Neurol 1998;11(4):305-309