Clearance follows last month’s sanction in the U.K., which will act as a reference member state.
GW Pharmaceuticals confirmed Spanish regulatory authority clearance for Sativex® as an add-on therapy for treating moderate-to-severe spasticity in multiple sclerosis patients who don’t respond adequately to other antispasticity drugs. Approval of the cannabinoid oromucosal spray in Spain follows on from approval of the drug in the U.K. in June.
GW’s marketing partner for Sativex in Europe (excluding the U.K.) is Almirall. The firms point out launch of Sativex in Spain will have to wait until pricing and reimbursement approval has been agreed to by the country’s ministry of health. They expect this final approval process to be completed during the fourth quarter of 2010.
GW Pharmaceuticals says it has also submitted an application for approval of Sativex in other EU countries via the European Mutual Recognition Procedure (MRP). The U.K. will act as the reference member state for the process. A full list of countries to which the MRP application relates has yet to be finalized.