Ottawa, Ontario: Health Canada has issued a "Qualifying Notice" for the approval of Sativex, an oral spray consisting of natural cannabis extracts, for the treatment of neuropathic pain associated with Multiple Sclerosis (MS). Health Canada is expected to finalize marketing authorization for Sativex by early 2005.
Produced by the British biotechnology firm GW Pharmaceuticals, Sativex is a whole plant medicinal cannabis extract containing precise doses of the cannabinoids THC and cannabidiol (CBD). In clinical trials, Sativex has been demonstrated to alleviate numerous MS-associated symptoms compared to placebo, including pain, muscle spasms, and bladder incontinence.
"This approval will be a major milestone for GW and for people with Multiple Sclerosis who have long awaited a prescription cannabis-based medicine for the treatment of neuropathic pain," GW's Executive Chairman Geoffrey Guy said in a prepared statement.
According to a 2003 University of Calgary survey, 16 percent of Canadians with MS have used cannabis therapeutically. Under Canadian law, patients with authorization from their physician may apply for permission from Health Canada to grow and possess cannabis for medicinal purposes.
GW is expected to seek further approval from Health Canada to market Sativex for additional indications, including chronic pain. Regulatory approval for Sativex in the United Kingdom remains pending. Earlier this month, an advisory body of the British Medicines and Health products Regulatory Agency (MHRA) announced that it required further clinical evidence of Sativex's ability to alleviate MS-associated spasticity in a "clinically relevant" manner before the agency would consider approving the drug for licensing in the UK.