Sativex FAQs

GW’s lead product, Sativex®, is approved and marketed in Canada for the relief of neuropathic pain in Multiple Sclerosis (MS) and cancer pain. Each of these approvals was secured under the Notice of Compliance with Conditions (NOC/c) policy. Following recent positive Phase III clinical trial results, Sativex® is currently the subject of a regulatory submission in the UK and Spain for the treatment of MS spasticity (muscle stiffness). An outcome of this submission is expected around the end of 2009 / early 2010. Sativex® is also in late stage development in the United States for the treatment of cancer pain.

Sativex® is GW's lead cannabinoid pharmaceutical product, standardized by both composition and dose, that is being developed for the treatment of conditions such as cancer pain, neuropathic pain of various origins, and symptoms of multiple sclerosis.

Sativex is administered as an oral spray which is absorbed by the patient’s mouth. It is composed primarily of a 1:1 ratio of two cannabinoids-CBD (cannabidiol-a non-psychoactive cannabinoid) and THC (delta-9-tetrahydrocannabinol). The CBD:THC formulation is believed to enhance the pain relief of THC while modulating the unwanted psychotropic and other THC-related side effects, such as tachycardia. The spray delivery system keeps THC from entering the blood too rapidly and also minimizes the development of unwanted psychotropic effects.

GW's clinical trials have generated over 1000 patient-years of safety data, and adverse events have been predictable and generally well tolerated. Many side effects occur primarily during the early stages of dose adjustment, while patients are identifying their optimal individualized dose and diminish over time or with reduced dose. The most common adverse events (> 10%) reported by patients in Sativex studies have been somnolence (sleepiness), nausea, and dizziness. These side effects are common to many other prescription medications, particularly pain medications.

No. Regulatory approvals from regulatory authorities such Health Canada are specific to Sativex® - there is no change in the law relating to cannabis. Any changes in regulations to permit Sativex to be prescribed would apply only to such an approved product and would have no direct consequence for the legal status of herbal cannabis for recreational and medical use. This is true for all countries around the world, including the United States.

In April 2005 GW received regulatory approval for Sativex® in Canada for symptomatic relief of neuropathic pain. In August 2007, Health Canada approved Sativex® as adjunctive analgesic treatment in patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain. Both approvals were secured under the Notice of Compliance with Conditions (NOC/c) policy. Sativex® is marketed in Canada exclusively by Bayer Healthcare.

In certain other countries, Sativex® is available on prescription on a named patient basis. In total, Sativex has been exported to 22 countries either for named patient prescription use or for clinical trials purposes.

In the US, Sativex® is an investigational drug being developed as an adjunctive (additive) analgesic treatment for patients with advanced cancer whose persistent pain has not been adequately relieved by optimized treatment with strong opioids. The FDA has not approved Sativex® and the product is not available in the United States other than for use in FDA approved clinical trials.

In Canada, Sativex is marketed by Bayer HealthCare. Once approved in the UK, Bayer will also market Sativex in that country. Upon approval in Europe (excluding the UK), Sativex will be marketed by Almirall. Upon approval in the United States, Sativex will be marketed by Otsuka.