Sativex® (delta-9-tetrahydrocannibinol and cannabidiol in the EU; nabiximols in the US) is an oromucosal spray of a formulated cannabis extract that contains the principal cannabinoids delta-9-tetrahydrocannibinol (THC) and cannabidiol (CBD), as well as specific minor cannabinoids and other non-cannabinoid components. We developed Sativex® to be administered as an oromucosal spray, whereby the active ingredients are absorbed in the lining of the mouth, either under the tongue or inside the cheek. Regulatory approval has been obtained in numerous countries outside the United States for the treatment of spasticity (muscle stiffness/spasm) due to multiple sclerosis (MS).*
All requests for product information and adverse events reporting should be directed through the individual websites for the distributors listed in the HCP section.
Nabiximols is an investigational product in the US, and the Company is commencing a pivotal clinical program to seek an initial FDA-approval for spasticity due to MS.
*See SmPC for full prescribing & safety information.