Sativex, a cannabis-based oromucosal spray for the treatment of spasticity due to multiple sclerosis (MS) will be launched in six additional European countries following approval in the UK and Spain last year.
The drug produced and marketed by GW Pharmaceuticals and Almirall SA has successful completed European Mutual Recognition Procedures and is expected to receive national approval in Germany, Italy, Denmark, Sweden, Austria and Czech Republic from mid 2011 onwards.
Almirall chief scientific officer Bertil Lindmark said that Sativex is the first drug which provides MS patients with a treatment option to mitigate spasticity and other related symptoms.
The last step in the regulatory process is for each country will now finalise local wording on product packaging and related documents and also to agree any other country-specific requirements.
A further submission will be made in 2011 with a view to expanding the approval of Sativex to additional European countries.
The drug is also in Phase III clinical development for the treatment of cancer pain.