Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Jul 28, 2010

Spain Approves Cannabis-Derived MS Therapy as GW Pharm Files for New EU Approvals

  • 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.

Related content

Be sure to take the GEN Poll

Cancer vs. Zika: What Worries You Most?

While Zika continues to garner a lot of news coverage, a Mayo Clinic survey reveals that Americans believe the country’s most significant healthcare challenge is cancer. Compared to other diseases, does the possibility of developing cancer worry you the most?

More »