Sativex®

Multiple sclerosis (MS) is commonest disabling neurological disease affecting the central nervous system (CNS) in young adults. It affects around 100, 000 in the UK and is most commonly diagnosed between the ages of 20 and 40. Women are twice as likely to be diagnosed as men.

Spasticity is an involuntary increase in muscle tone. When the muscle is moved, there is more resistance to this movement than there normally would be and the muscle feels stiff or rigid. Increased tone can mean muscles are slow to relax, and this can cause stiffness. Spasticity may also cause them to jerk in an uncontrolled way. This is one kind of muscle 'spasm' that people with MS can experience. If muscles jerk repeatedly, this is known as 'clonus' for example when a foot taps repetitively on the floor.

There is no evidence to suggest that Sativex® produces a ‘high’ comparable to recreational cannabis.

One of the cannabinoids in Sativex is THC whereas the other principal cannabinoid is CBD, a non-psychoactive molecule. Evidence suggests that CBD may modulate many of the unwanted effects of THC. Hence, through the incorporation of CBD and the utilization of an oromucosal spray delivery system which is administered through careful self-titration (dose adjustment) and which keeps THC from entering the blood too rapidly, patients are able to obtain symptom relief without experiencing a 'high'. Patients emphasise that they seek to obtain the medical benefits without intoxication and, when taking Sativex, are able to adjust their dose to achieve symptom improvement with the minimum of unwanted effects.

However as with all medicines, there is the potential for Sativex® to cause unwanted effects such as dizziness or fatigue when it is first used.

Cannabinoids react with cannabinoid receptors that occur naturally throughout our bodies, including in our brains. A receptor is a site on a brain cell where certain substances can stick or “bind” for a while. If this happens, it has an effect on the cell and the nerve impulses it produces, which causes a ‘dimming down’ of the symptoms of spasticity. In patients who respond to Sativex®, it is this effect which helps to improve their symptoms of spasticity and to help them cope better with their usual daily activities.

Main effects of CBD: Anti-inflammatory, anticonvulsant, antipsycotic, anti-oxidant, neuroprotective, immunomodulatory

Main effects of THC: Analgesic, anti-spasmodic, anti-tremor, anti-inflammatory, appetite stimulant, anti-emetic

In the UK and Canada, Sativex is marketed by Bayer Schering Pharma. In Europe (excluding the UK), Sativex will be marketed by Almirall. Upon approval in the United States, Sativex will be marketed by Otsuka.

In the UK, Sativex has just been approved and launched as a prescription medicine as a treatment for spasticity due to multiple sclerosis.

In Canada, Sativex is approved under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy for the relief of neuropathic pain and advanced cancer pain.

In Spain, Sativex is expected to be approved shortly and launched in H2 2010. Further submissions will be made to additional European countries in H2 2010 under the mutual recognition procedure and we anticipate approvals in other European countries in H1 2011. In certain other countries, Sativex® is available on prescription on a named patient basis. In total, Sativex has been exported to 28 countries either for named patient prescription use or for clinical trials purposes.

In the US, Sativex® is an investigational drug being developed as an adjunctive (additive) analgesic treatment for patients with advanced cancer whose persistent pain has not been adequately relieved by optimized treatment with strong opioids. The FDA has not approved Sativex® and the product is not available in the United States other than for use in FDA approved clinical trials.

No. Regulatory approvals from medicines regulatory authorities are specific to Sativex® - there is no change in the law relating to cannabis. Any changes in regulations to permit Sativex to be prescribed would apply only to such an approved product and would have no direct consequence for the legal status of herbal cannabis for recreational and medical use. This is true for all countries around the world, including the United States.

GW's clinical trials have generated over 1300 patient-years of safety data, and adverse events have been predictable and generally well tolerated. The most common side effects of Sativex® are dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued. These side effects are common to many other prescription medications, particularly pain medications.

Sativex is the world’s first prescription medicine derived from the cannabis plant. The medicine is standardized by both composition and dose and is being developed for the treatment of conditions such as spasticity in multiple sclerosis, cancer pain, and neuropathic pain of various origins

Sativex is administered as an oral spray which is absorbed by the patient’s mouth. Sativex® contains active ingredients called ‘cannabinoids’, which are extracted from cannabis plants grown and processed under strictly controlled conditions. It is composed primarily of a 1:1 ratio of two cannabinoids-CBD (cannabidiol-a non-psychoactive cannabinoid) and THC (delta-9-tetrahydrocannabinol). The CBD:THC formulation is believed to enhance the therapeutic benefits of THC while modulating the unwanted psychotropic and other THC-related side effects, such as tachycardia. The spray delivery system keeps THC from entering the blood too rapidly and also minimizes the development of unwanted psychotropic effects.