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Sativex® is GW's lead cannabinoid pharmaceutical product, administered as an oral spray which is absorbed by the patient’s mouth. In April 2005 GW received regulatory approval for Sativex® in Canada for symptomatic relief of neuropathic pain in Multiple Sclerosis. 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 currently undergoing late stage clinical development in Europe and the United States. 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 (ex-UK), Sativex® will be marketed by Almirall. Upon approval in the United States, Sativex® will be marketed by Otsuka. The current position regarding the availability of Sativex® varies between different countries according to whether Sativex® has been approved by the medical regulatory authority in the country and also on the local regulations regarding the prescribing of controlled drugs and unlicensed medicines. |
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