Cancer :: Health Canada approves Sativex for cancer pain

GW Pharmaceuticals plc (AIM: GWP) and Bayer Inc., a subsidiary of Bayer AG, announce that Health Canada has approved Sativex?, a cannabis derived pharmaceutical treatment, 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.

Sativex, the only pharmaceutical product derived from components of the cannabis plant, is administered through a spray into the patient?s mouth.

Health Canada has approved Sativex with conditions, under the Notice of Compliance with Conditions (NOC/c) policy. This authorization reflects the promising nature of the clinical evidence which will be confirmed with further studies. Products approved under Health Canada?s NOC/c policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use.

In 2005, Health Canada approved Sativex for the treatment of neuropathic pain in adults with multiple sclerosis (MS) under the NOC/c policy.

Sativex is a buccal spray composed primarily of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), a non-psychoactive cannabinoid. The product is standardized by both composition and dose. Sativex is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.1 These receptors are distributed throughout the pain pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.

Dr. Geoffrey Guy, GW?s Chairman, commented: ?GW is delighted to receive Health Canada?s regulatory approval for Sativex in the relief of cancer pain. Sativex has been shown to provide important pain relief to the most high need patients with advanced cancer. We are pleased to be able to offer the prospect of an improved quality of life for people who previously had little such opportunity.?

?Bayer HealthCare is committed to putting the needs of patients first and is very pleased that Sativex can now be used to manage cancer pain in Canada,? said Philip Blake, president and CEO, Bayer Inc. ?Health Canada?s approval of Sativex is further recognition of the important role this medicine can play in effective pain treatment.?

?Cancer pain is not managed as well as it could be and the resources available to manage cancer pain effectively are still somewhat limited. Cannabinoids have an important role in treating complex cancer pain particularly neuropathic pain and demonstrate a positive effect with current treatment options,? said Dr. Lawrence Librach, Director of the Temmy Latner Centre for Palliative Care at Mount Sinai Hospital and Vice President of the Canadian Hospice Palliative Care Association.


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