By Paul Armentano
British health regulators have approved the sale and marketing of Sativex, an oral spray consisting of natural cannabis extracts (primarily the plant cannabinoids THC and cannabidiol aka CBD) as a treatment for symptoms of multiple sclerosis. (MS)
The spray, which has been legally available to patients in Canada since 2005, went on sale in Britain on Monday. The drug will be marketed in the United Kingdom by the Bayer Corporation which estimates that Sativex will cost the country’s state-run National Health Service roughly £11, or about $16, a day for each patient.
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Commenting on the drug’s regulatory approval, NORML Deputy Director Paul Armentano said: “The approval of Sativex in the UK is newsworthy though hardly surprising, as the scientific evidence in support of marijuana’s medical safety and utility has been available for decades. However, the bigger question still remains. That is: ‘How can the US government continue to promote a policy that calls for the arrest and prosecution of patients who use a substance that fourteen states and much of the rest of the western world now acknowledges as a safe and legitimate medicine?’”
In clinical trials, Sativex has been demonstrated to reduce MS-associated spasticity, pain, and incontinence. Long-term investigational trials indicate that consistent use of the cannabis-based medicine may also slow the progression of the disease.
Surveys from the UK and elsewhere indicate that MS patients often report using cannabis therapeutically, with one study reporting that some four out of ten patients with the disease find relief from marijuana.
GW Pharmaceuticals, makers of the Sativex, is expected later this year to seek separate regulatory approval for the spray in Spain, France, Germany, and Italy.
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In 2006, the US Food and Drug Administration authorized recruitment for the first-ever North American clinical trial of Sativex for cancer pain treatment. A Phase III trial is anticipated to begin the US later this year.