Sativex^®: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain

Abstract

Sativex^® is one of the first cannabis-based medicines to undergo conventional clinical development and to be approved as a prescription medicine. It is an oromucosal spray that allows flexible, individualised dosing. Patients self titrate their overall dose and pattern of dosing according to their response to and tolerance of the medicine. This usually results in the administration of ∼ 8 – 12 sprays/day. Each spray delivers tetrahydrocannabinol 2.7 mg and cannabidiol 2.5 mg, giving an approximate average dose of tetrahydrocannabinol 22 – 32 mg/day and cannabidiol 20 – 30 mg/day. Development has concentrated on the treatment of symptoms of multiple sclerosis, notably spasticity and neuropathic pain, as well as the treatment of neuropathic pain of other aetiologies. Positive results in placebo-controlled trials of the use of Sativex as an add-on therapy in these indications demonstrate that Sativex is efficacious and well tolerated in the treatment of these symptoms. Sativex has been approved for use in neuropathic pain due to multiple sclerosis in Canada. If ongoing studies replicate the results already observed, further approvals for the treatment of spasticity in multiple sclerosis and for neuropathic pain are likely.

Keywords::

• cannabis
• multiple sclerosis
• neuropathic pain
• Sativex^®
• spasticity

Conflict of interest

The author acknowledges the assistance of GW Pharmaceuticals with regard to access to clinical trial data. Many of the GW Pharmaceuticals studies have not yet been published in the peer-reviewed literature. Further details are available from the company at GW Pharmaceuticals PLC, Alexander House, Forehill, Ely, Cambridgeshire, CB7 4ZA, UK.

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