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The health authorities in Denmark have granted regulatory approval for Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to MS in patients who have not responded adequately to other anti-spasticity medication.
Regulatory approval for Sativex® has been granted after the recent change in the local laws. Sativex® is a first in class endocannabinoid system modulator for the treatment of spasticity in MS, currently available in the UK and Spain.
Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder or sleep disturbance. By relieving the symptoms of MS, Sativex® can improve patients’ quality of life and allow them greater independence in performing their daily activities.
Approval in Denmark follows successful completion in March 2011 of the European Mutual Recognition Procedure (MRP) with all countries involved recommending approval. Approval for Sativex® was granted in Germany on 26th May 2011 and the product is expected to be launched there in July. In addition to Germany and Denmark, launch is also expected in Sweden before the end of 2011. Launches in Italy, Czech Republic and Austria are expected in 2012.
A further MRP is planned for later 2011 involving other European countries, in order to make this medicine available to more patients suffering from MS.
Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).