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World’s first prescription cannabis medicine launched

The UK launch of Sativex®, GW Pharmaceuticals’ oromucosal spray for the treatment of spasticity caused by multiple sclerosis, has been announced.

Sativex is the world’s first prescription cannabis medicine, and the UK is the first country in the world to grant a full regulatory authorization for the product.

Sativex is primarily composed of a 1:1 ratio of two cannabinoids: cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). The CBD–THC formulation is believed to provide a good balance of clinical effect (a significant decrease in multiple sclerosis, or MS, spasticity) to THC-related side-effects.

Sativex, available as a prescription-only medicine, was developed in response to calls from people with MS for a prescription cannabis-based medicine. Today's launch means that MS patients suffering the spasms and cramping associated with spasticity have access to a new treatment option that might improve their symptoms where current treatments have failed.

Clinical trials have indicated that approximately half of all people who add Sativex to their existing medication will find that it can provide relief from the debilitating symptoms of spasticity associated with MS.

Dr Geoffrey Guy, GW’s Chairman, said: ‘The approval and launch of Sativex in the UK is the world’s first full approval of a cannabis-derived prescription medicine and the product of eleven years’ research by GW into the cannabinoid system. GW was founded with the primary goal of developing a medicine to address the unmet needs of people with MS and today’s launch of Sativex represents a welcome advance in MS symptom treatment.’

MS is a condition that affects approximately 100,000 people in the UK. Spasticity is a common symptom associated with MS and is a major contributor to disability.

Moderate, severe or total spasticity is reported in 34% of individuals, and symptoms include loss of mobility, painful spasms, stiffness and/or weakness of muscles. As a consequence, an individual might have difficulty in walking, picking up objects, washing and dressing or with other everyday activities involving movement.

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Biotherapeutics  •  Regulatory


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