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Saturday, September 23, 2006
NEW MS MED IN EUROPE: "Sativex, the cannabis-derived product could be finally set for approval after a delay of around two years...FULL STORY:
Sativex is already approved in Canada to treat MS neuropathic pain and the company recently started a further phase III study in this indication. UK regulator, the MHRA, rejected the drug in December 2004, calling for a second clinical trial to prove its efficacy, which the company has now conducted, and which, it believes, proves that Sativex works. Dr Stephen Wright, GW's R&D Director said: "We now have a sizeable body of positive clinical data to support the efficacy and safety of Sativex in MS spasticity. This is a complex data package and we have therefore reviewed the complete dossier with our marketing partners and discussed it in detail with a number of European regulators. The company is seeking to treat multiple sclerosis spasticity, but hopes to eventually gain licences to treat peripheral neuropathic pain, MS neuropathic pain and cancer pain as well. GW Pharmaceuticals has filed Sativex for approval through the decentralised procedure for licences in just four European countries, the UK, Denmark, Spain and the Netherlands......" |