Sativex® (delta-9-tetrahydrocannibinol and cannabidiol in the EU; nabiximols in the US) is an oromucosal spray of a formulated extract of the cannabis sativa plant that contains the principal cannabinoids delta-9-tetrahydrocannibinol (THC) and cannabidiol (CBD) in a 1:1 ratio 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 over 25 countries outside the United States for the treatment of spasticity (muscle stiffness/spasm) due to MS.
GW does not market Sativex® directly. 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 planning to seek FDA-approval.
Sativex® is also under development for potential indications in schizophrenia and other neurological conditions.