GW Pharmaceuticals has announced that its marijuana-based drug Sativex will be available on a limited basis to patients in England and Spain. The tincture, applied through a sublingual spray, is currently available by prescription only in Canada. The primary market will be Multiple Sclerosis and cancer patients, although it will be used for other diseases and conditions as well.
Last week, GW announced it had reached an agreement with the Regional Government of Catalonia in Spain to supply Sativex to 600 patients, with initial shipments going out within weeks. 130 of the patients will be MS sufferers, 130 more are neuropathic pain patients, 300 are cancer patients suffering nausea and vomiting from chemotherapy, and 40 more are patients suffering from AIDS wasting syndrome.
The move came at the initiative of the Catalan Health Department, which was responded to patient and doctor requests, and was approved by the Spanish Ministry of Health. The department has already budgeted funds to pay for the drug. The compassionate access program will be evaluated for safety and tolerability
Dr. Rafael Manzanera, General director of Health Resources of the Catalan Health Department, said, "This is a direct response to the wishes of patients with a significant unmet medical need. The Catalan administration believes that a non-smoked prescription cannabis derived medicine, such as Sativex, represents the optimum solution for these patients, without in any way promoting the use of herbal cannabis," said Dr. Rafael Manzanera, general director of health resources for the department.
This week, GW announced that England would become the second European country to make Sativex available to some patients. According to GW, the British Home Office has decided that the drug may be imported from Canada as an unlicensed medicine for prescription to individual MS patients by their doctors. Sativex is yet to be licensed in Britain, but under the Medicines Act, such products may be prescribed if doctors decide it is in the best interest of a particular patient. The government acted in response to inquiries from doctors and patients, GW said.
"This is a move in the right direction," Mike O'Donovan, head of the British MS Society told the BBC. "We believe there is now good evidence that cannabis-derived medicine can relieve distressing symptoms like spasticity and pain in MS. Many people do not find available treatments effective and will now have the opportunity to try a new drug which could significantly improve their quality of life. "We very much hope it will not be long before it is licensed for NHS prescription."
So does GW. The company says it continues "to seek full regulatory approval... for Sativex in the UK." It is conducting Phase III clinical trials and plans to submit an application for marketing authorization next year.