GW Pharmaceuticals plc and Almirall, S.A have announced that regulatory authorities in the UK and Spain have reached consensus that all issues related to the Sativex® application have been resolved, with a positive recommendation that Sativex® is approvable. The regulatory process will now enter the national phase to finalise local wording on product packaging and related documents. After this phase, national marketing approvals can be granted in each respective country (likely second quarter 2010). Sativex®, an endocannabinoid system modulator, administered through an oromucosal spray, is indicated as add-on treatment for symptom improvement in patients with spasticity due to multiple sclerosis, who have not responded adequately to other anti-spasticity medication.

The Sativex regulatory submission was filed in the UK and Spain under the European decentralised procedure in May 2009, with the UK acting as the Reference Member State.