Europe opens up for cannabis-based medicine men
GW Pharmaceuticals plc in Cambridge, the cannabis-based medicines specialist, has received approval in Austria for a key product.
Sativex® has received regulatory approval in Austria as a treatment of spasticity due to Multiple Sclerosis.
The launch of Sativex in Austria is expected to take place during 2012 following completion of the national pricing and reimbursement process. It will be marketed in Austria by GW's marketing partner, Almirall S.A.
GW Pharma has also been handed a boost in its bid to extend approvals for other uses into other European territories.
Last November it filed a new regulatory application, under the European Mutual Recognition Procedure (MRP), to expand Sativex approvals to additional European countries.
Now the company says that the dossier has been validated and is under technical review by regulatory authorities in Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia. It is expected that this new MRP process should complete around mid-2012.
Sativex is currently available as a prescription medicine in the UK, Spain, Germany, Denmark, Canada and New Zealand. Launches are expected during 2012 in Italy, Sweden, Austria and the Czech Republic.
The product is also in Phase III clinical development as a treatment for cancer pain.