Approval in Spain of GW Pharmaceuticals’ Sativex is expected shortly.

GW Pharmaceuticals and Bayer Schering Pharma have launched the first cannabinoid medicine derived from whole Cannabis sativa plant extracts with approval in the U.K. for the treatment of spasticity due to multiple sclerosis (MS). Sativex is an oromucosal spray, discovered and developed by GW Pharmaceuticals. The company will receive a £10 million milestone payment from Bayer with the U.K. approval.

Outside the U.K. Sativex is expected to be approved in Spain shortly. Further submissions will be made in additional European countries during the second half of this year under the mutual recognition procedure. Almirall will market Sativex in Europe (ex-U.K.).

Sativex contains two cannabinoids: THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). It is the first cannabinoid medicine derived from whole Cannabis sativa plant extracts. 

“We have been aware for a long time, based on comments from people with MS, that cannabis-based medicines can significantly improve spasticity, which is a common, complex symptom of MS,” comments Pam Macfarlane, chief executive of the MS Trust. “For this reason the MS Trust has campaigned for the availability of a licensed medicine that can be properly controlled and prescribed. We have also invested money and resources in developing the body of knowledge by funding clinical research into the effectiveness of cannabis-based medicines. The launch of Sativex is therefore a milestone for the NHS and the MS Trust, and we are delighted.”

Geoffrey Guy, M.D., GW’s chairman, points out, “The approval and launch of Sativex in the U.K. is the world’s first full approval of a cannabis-derived prescription medicine and the product of 11 year’s research by GW into the cannabinoid system.”

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