Almirall files Sativex in UK and Spain
Almirall has filed a regulatory submission for its cannabis-based mouth spray Sativex in the treatment of spasticity due to multiple sclerosis in the UK and Spain under European procedures. The Medicines and Healthcare products Regulatory Agency (MHRA) is acting as Reference Member State. This submission follows the recent announcement of positive results in a Phase III study where Sativex showed relevant improvement of the spasticity's evolution in MS patients. It is expected that an outcome of the regulatory submission will be known around the end of 2009 or early 2010. Following approval in the UK and Spain, submissions for approval would be made in other European countries during 2010.
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