Sativex is a drug that contains two main compounds derived from marijuana, the cannabinoids cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC). It controls involuntary muscle movements in people with multiple sclerosis (MS). It also has been shown to help with MS-related pain, spasticity and bladder dysfunction. It is sprayed into the mouth.
Sativex is currently in a Phase III trial in the US for treatment of cancer pain, which is a necessary step for receiving FDA approval.† Once FDA approval is received for Sativex, it can be used off-label to help people with MS. (For more information on how this works, read What is "off-label" use of drugs and is it legal?)
Sativex is currently approved in the UK, Spain, Czech Republic, Canada and New Zealand as a treatment of multiple sclerosis spasticity.
The US license to Sativex is held by Otsuka Pharmaceutical Co. Ltd in the United States and to Bayer HealthCare AG in the UK and Canada. GW Pharmaceuticals has signed a deal to have Novartis (makers of Gilenya) market Sativex in parts of Asia, the Middle East, Australia, New Zealand and Africa, so is moving ahead in those markets.