For the treatment of spasticity due to Multiple Sclerosis (MS)
The health authorities in Denmark have approved GW Pharmaceuticals’ Sativex (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray.
The approval has been given to the cannabis-based treatment, the first in Denmark, 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.
The product should be launched in Denmark later this month.
Approval for Sativex was granted in Germany last month and the product should be launched there in July. Sweden will follow before the end of 2011. Launches in Italy, Czech Republic and Austria are expected in 2012.
Sativex, which has been developed by GW Pharmaceuticals, is also in Phase III clinical trials for the treatment of cancer pain, which will be the next indication following MS spasticity.
Almirall, headquartered in Barcelona, Spain, holds the marketing rights to this medicine in Europe (except the UK).