GW is pleased to announce that, following the receipt of regulatory approval from Health Canada, Sativex is now available by prescription through Canadian pharmacies as an adjunctive treatment for symptomatic relief of neuropathic pain in adults with multiple sclerosis (MS).
GW is pleased to announce that, following the receipt of regulatory approval from Health Canada, Sativex is now available by prescription through Canadian pharmacies as an adjunctive treatment for symptomatic relief of neuropathic pain in adults with multiple sclerosis (MS). In April 2005, Canada became the first country in the world to approve Sativex, an effective and safe cannabis derived prescription medicine.
Sativex is manufactured in the UK by GW and its contract manufacturing partners. The product is being marketed in Canada by Bayer HealthCare, Pharmaceuticals Division, GW’s marketing partner.
Sativex is administered through a spray pump under the tongue or on the inside of the cheek, providing reliable, self-administered pain relief. Its principal active cannabinoid components are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Sativex is a pharmaceutical product standardised in composition, formulation, and dose. While there is no complete cure for MS or neuropathic pain, a double-blind placebo controlled parallel group study demonstrated that Sativex provided significantly greater pain relief than placebo. Sativex also significantly reduced pain-related sleep disturbance.
MS is a disease of the central nervous system and is the most common neurological disease affecting young adults in Canada. It is estimated that 50 per cent of people with MS suffer from chronic neuropathic pain1,2,3. Approximately 50,000 Canadian men and women have the disease4.
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
Bayer inc.:+ 001 416 240 5252
Lori Ann Horrigan
About GW Pharmaceuticals plc
GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development program 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 programme 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.
1 Archibald CJ, et al. Pain 1994; 58:89-93.
2 Sketris IS, et al. Clinical Therapeutics 1996; 18(2):303-318.
3 Moulin DE, et al. Neurology 1988;38:1830-1834.