The UK Government has said it will allow limited imports of Sativex from Canada, where it has been launched by licensee Bayer. Patients with MS will be able to import the drug, approved in Canada for the relief of neuropathic pain in adult MS patients, for personal use. Legally it will remain a controlled drug in the UK, available only under a Home Office license.
“This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex,” said GW in a statement.
GW had originally hoped to launch Sativex in the UK in 2003, but has suffered a number of hold-ups on the route to market. Most recently, in June, the company was told by regulators that it would have to conduct an additional clinical study before approval could be granted.
The company said it is currently conducting a number of further Phase III trials and is still planning to submit Sativex for approval in the UK during 2006.