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news.The health authorities in Denmark have granted regulatory approval to Sativex oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to multiple sclerosis (MS) in patients who have not responded adequately to other anti-spasticity medication.
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Developed by GW Pharmaceuticals, Sativex (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) is 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 UK).
Evidence generated from clinical trials shows that Sativex has a positive impact on spasticity in MS, while alleviating associated symptoms including pain, bladder or sleep disturbance.
Sativex was approved in Germany in May 2011 and the drug 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.