Almirall has announced the filing of new applications for its Sativex endocannabinoid oromucosal spray for the treatment of spasticity in multiple sclerosis in ten additional countries: Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia. The product is currently available in Denmark, Germany, Spain, UK, Canada, and New Zealand. GW Pharmaceuticals, which developed Sativex, holds the Marketing authorization; Almirall holds the marketing rights in Europe except in the UK.
Almirall Chief Scientific Officer Bertil Lindmark commented, “We are excited by this opportunity of broadening the geographical accessibility of the unique benefits of Sativex alleviating symptoms of spasticity in patients with MS.” The company expects a response under the Mutual Recognition Procedure (MRP) by mid-2012, after which the individual countries would proceed with their individual approval processes.
Read the Almirall press release.
