 | Sativex: Sativex denied approval |
 Major blow for medical cannabis worldwide. Approval not likely for two years!
Sativex, the under the tongue spray of whole plant-extracts has been denied approval for sale by UK regulators. The Committee on Safety of Medicines (CSM), an advisory body to the Medicines and Healthcare products Regulatory Agency (MHRA), noted that Sativex met the criteria for quality and safety, but they felt that the evidence for efficacy was not strong enough. They recognised that Sativex had a clinical effect on spasicity in multiple sclerosis, but they questioned the clinical "relevance" of the effect for patients.
The news was greeted with surprise and dismay by scientists involved with the trials and by patients groups who felt that the evidence was so strong that Sativex must be approved. The UK regulators had previously forced GW Pharmacueticals to only supply a single clinical study to support their application, rather than looking at all the evidence.
GW Pharmacueticals are able to appeal the decision, but this will take six months. They have started the trial that the regulators have asked for but that will not be finished until the end of 2005 at the earliest.GW are pinning their hopes on selling Sativex in countries where cannabis is allowed as medicine such as Canada, but the GW share price fell by a quarter at the news.
The decision is bad news for New Zealand cananbis patients as well since the Ministry of Health justifies stalling on medical cannabis by the fact that Sativex has not been approved yet.
 04/12/04 Anger As Cannabis Drug Fails MS Trial
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