Sativex approved in Sweden
For the treatment of spasticity due to multiple sclerosis
The Medical Products Agency in Sweden has granted regulatory approval to GW Pharmaceuticals’ cannabis-based medicine Sativex as a treatment for moderate to severe spasticity due to multiple sclerosis.
Sativex (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray is currently available in the UK, Germany, Spain and Denmark.
Clinical trials have shown that the drug has a positive impact on spasticity in MS, while alleviating associated symptoms including pain, bladder or sleep disturbance.
Sativex is also in phase III clinical development for the treatment of cancer pain.
GW’s marketing partner Almirall will start marketing the drug in Sweden during the first half of 2012 following completion of the national pricing and reimbursement process.
Almirall holds the marketing rights to this medicine in Europe (except the UK).