International expansion of UK firm GW Pharma's cannabis-based spray Sativex is well underway after a further 10 European countries recommended approval of the drug for multiple sclerosis patients.
Health Authorities in Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia have now given the go-ahead for Sativex (delta-9-tetrahydrocannabinol and cannabidiol), completing its Mutual Recognition Procedure in Europe.
This means that Sativex can be marketed in these countries as an add-on therapy for the treatment of moderate to severe spasticity due to MS in patients who have not responded adequately to other medication, and launches are expected from the end of this year onwards.
The product is already available in the UK, Spain, Germany and Denmark, and further launches are currently in preparation in Italy, Sweden, Austria and Czech Republic, the firm said.
Spasticity is a common symptom of MS being widely defined as muscle spasms, seizing-up, stiffness and/or difficulty in moving muscles. It is estimated to affect 500,000 patients with MS in the European Union's five main markets alone, having a serious impact on quality of life and being costly to treat for health systems.
Sativex is the world's first cannabis-based drug on the market. According to data from two Phase III trials, published in the European Journal of Neurology last year, about half of MS patients who had failed to respond to standard therapy experienced an improvement in spasticity after the drug, clearly demonstrating its efficacy.
The treatment, which is sprayed into the mouth, will be sold in Europe by Spanish drugmaker Almirall, except for in the UK, where Bayer holds the license, while Novartis has partnered with GW Pharma in Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), the Middle East (excluding Israel/Palestine) and Africa.
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