GW submits New Drug Submission for Sativex®, Cannabis-Based Medicine, to Health Canada

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May 11, 2004

Sativex has been developed by GW and, subject to approval, will be exclusively marketed in Canada by the Pharmaceuticals Division of Bayer HealthCare.

Sativex has been developed to provide a cannabis-derived pharmaceutical product for the treatment of the debilitating symptoms of Multiple Sclerosis (“MS”) and severe neuropathic pain. The product is a whole plant medicinal cannabis extract containing TetranabinexTM (tetrahydrocannabinol or THC) and NabidiolexTM (cannabidiol or CBD) as its principal components. The medicine is administered by means of a spray into the mouth.

Approximately 50,000 people in Canada are diagnosed with Multiple Sclerosis. Pain is a common symptom in MS and significant pain occurs in 42–65% of all MS patients.1 A survey of Canadian patients with neuropathic pain cited a 72.8% finding of inadequate pain control.2

Dr Geoffrey Guy, Executive Chairman of GW, said, “In recent years, GW has conducted an active and positive dialogue with Canadian officials regarding the introduction of Sativex. Subject to regulatory approval, we now look forward to bringing a non-smoked, cannabis-based prescription medicine to market in Canada.”

Philip Blake, President of Bayer Inc., said, “We are very pleased to be working in partnership with GW to bring this innovative medicine to the Canadian market once it has been approved. MS patients often suffer from pain associated with this disease. We hope that Sativex offers another treatment option.”

GW submitted a product licence application for Sativex to the UK Medicines and Healthcare products Regulatory Agency in March 2003.


1Boivie, J. Central Pain, Textbook of Pain, 1999; 879-914

2Gilron I, et al., Patients’ attitudes and prior treatments in neuropathic pain: a pilot study. Pain Research and Management 7 (4): 1999-203, 2002.

- Ends -


GW Pharmaceuticals plc

01980 557000

Dr Geoffrey Guy, Chairman

Justin Gover, Managing Director

Mark Rogerson, Press and PR

07885 638810

Weber Shandwick Square Mile

020 7067 0700

Kevin Smith

Notes to Editors

A New Drug Submission is the application for the marketing authorization of a new prescription medicine to enable sale and distribution in Canada.

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. Full details of GW and the company’s clinical trials programme can be found at

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. GW’s team is also supported by a number of prominent scientific advisers in this field in Europe and North America.

Bayer HealthCare, a subgroup of Bayer AG with sales of approximately 8.9 billion Euro in 2003, is one of the world’s leading, innovative companies in the health care and medical products industry.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events, including the clinical development and regulatory clearance of the Company's 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 the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and the Company'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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