Canada: Sativex gets approval
Sativex gets approval for the treatment of neuropathic pain in multiple sclerosis.
On 19 April the British company GW Pharmaceuticals announced that their cannabis extract Sativex has been granted regulatory approval in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis. According to a statement by the company the drug is likely to be launched in May and the price would only be announced shortly before launch.
Dr. Geoffrey Guy, Executive Chairman of the company, said, "We are delighted that Sativex has received regulatory approval in Canada. This event marks the world’s first approval of a cannabis derived medicine. This first regulatory approval has been obtained by GW in just over six years since the Company’s development programme commenced, a highly significant achievement. We are now working with our Canadian marketing partner, Bayer, towards the launch of Sativex throughout Canada in late spring."
The approval had been expected after Canadian regulators said last December that Sativex, which is sprayed under the tongue and contains equal amounts of THC and CBD, is qualified to be considered for approval. The company had originally hoped to win British approval for Sativex in 2003 but UK officials said in December they wanted more evidence about the benefits of the medicine. It is not expected to be approved in its home market until later this year or possibly 2006. Nevertheless, Guy said he was confident the drug would win approval in major markets around the world.
The approval of Sativex was welcomed by the MS Society of Canada, whose national medical adviser Dr. William McIlroy said sufferers needed new options to address their pain.
(Sources: Press release by GW Pharmaceuticals of 19 April 2005, Reuters of 19 April 2005)
