GW Pharmaceuticals has announced that the health regulators in Spain have granted approval for Sativex, the world’s first cannabis-based prescription drug.
The Spanish authorities have given the go-ahead for Sativex (delta-9-tetrahydrocannabinol and cannabidiol) to be used as an add-on therapy for the treatment of moderate to severe spasticity due to multiple sclerosis in patients who have not responded adequately to other medication. Prior to launch, Sativex needs to get pricing and reimbursement approval from the Spanish Ministry of Health, which is expected to be completed during the fourth quarter.
GW noted that it has submitted an application under the European Mutual Recognition Procedure to seek marketing authorisation in most of the continent’s member states, including the major commercial markets of France, Germany and Italy. The UK’s Medicines and Healthcare product Regulatory Agency approved Sativex in June 2010.
The treatment, which is sprayed into the mouth either onto the inside of the cheek or under the tongue, will be sold in Europe by Spanish drugmaker Almirall, except for in the UK, where Bayer holds the licence.
Justin Gover, GW’s managing director, said the Spanish approval and filing of the European mutual recognition submission “marks the beginning of the international expansion of this product”.
