The approval has been granted for Sativex as an add-on therapy to treat moderate to severe spasticity due to multiple sclerosis (MS) in patients who have not responded adequately to other anti-spasticity medication.
Almirall and GW Pharma expect to introduce the drug in the German market in July 2011 and before the end of 2011 in Denmark and Sweden.
Further, Sativex will be launched in Italy, Czech Republic and Austria in 2012.
Developed by GW Pharma, Sativex currently is in Phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity.
However, Almirall holds the marketing rights to this medicine in Europe (except the UK).