A cannabis-based prescription drug to treat the symptoms of multiple sclerosis has been approved in the UK.
GW Pharmaceuticals’ Sativex is an oromucosal spray that reduces the spasms and cramping associated with spasticity. It contains two active ingredients from the cannabis sativa plant, THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol).
The UK is the first country in the world to grant a full regulatory authorisation for the product, which will be available as a prescription-only medicine.
GW Chairman Dr Geoffrey Guy said that this approval is the product of 11 years of the company’s research into the cannabinoid system, and represents a welcome advance in the treatment of multiple sclerosis symptoms.
The medicine is being marketed in the UK by GW’s licensee, Bayer Schering Pharma. GW will receive a £10m milestone payment from Bayer following the approval.
Sativex is also expected to gain approval in Spain and further submissions will be made across Europe during the second half of 2010.
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