GW Pharmaceuticals plc and Bayer Inc., a subsidiary of Bayer AG, announced that Health Canada has approved Sativex [delta-9-tetrahydrocannabinol 27 mg/mL (from Tetrabinex - cannabis sativa L. extract) and cannabidiol 25 mg/mL (from Nabidiolex - cannabis sativa L. extract)] as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS). Sativex is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant containing both delta-9-tetrahydrocannabinol and cannabidiol. This means that people in Canada with MS experiencing the debilitating symptoms of spasticity, such as painful spasms and cramps, will now have a new treatment option in addition to standard therapy.

The MS spasticity indication has received a full marketing authorization, or Notice of Compliance (NOC), from Health Canada. Sativex is useful as adjunctive treatment for symptomatic relief of spasticity in adult patients with MS who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy. In addition to this new NOC, Health Canada approved Sativex in 2005 under its Notice of Compliance with Conditions (NOC/c) policy as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis, and granted a further NOC/c approval in 2007 as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.

“Health Canada’s approval of a third indication for Sativex demonstrates the broad applications of this medicine,” said Dr Shurjeel Choudhri, chief medical officer and Head, Medical and Scientific Affairs, Bayer Inc. “Sativex meets a significant unmet medical need by improving the symptoms of spasticity in patients with MS who have failed to respond to current anti-spasticity medication. We believe that this approval represents an important step forward in the available treatment options for the MS patient population in Canada.”

Dr Stephen Wright, R&D director, GW, said: “Following recent approvals in the UK and Spain, Canada is now the third major country to approve Sativex for symptomatic relief of spasticity in adult patients with MS. This regulatory approval has come several months earlier than anticipated and GW looks forward to working with Bayer to develop the marketing strategy for this new indication. We are delighted that the international regulatory programme for Sativex is continuing its positive momentum.”

A product resulting from the pioneering research efforts of UK-based GW Pharmaceuticals plc and marketed in Canada by Bayer HealthCare Pharmaceuticals, Sativex contains active ingredients called ‘cannabinoids’, which are extracted from cannabis plants grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.

The principal active cannabinoid components of Sativex are THC and CBD, a non-psychoactive cannabinoid. The ratio of THC to CBD in Sativex is 2.7mg:2.5mg per spray, ensuring a standardized dose is delivered each time it is used.3

Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada.

GW was founded in 1998 and is listed on the AiM, a market of the London Stock Exchange. Operating under licence from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular MS and cancer pain.