GW Sativex Neuropathic Pain Trials Review

In April 2005 GW announced its first regulatory approval (NOC/c) for Sativex® in Canada for the symptomatic relief of neuropathic pain in adults with Multiple Sclerosis.

GW has reported positive results from Phase III neuropathic pain trials covering the following indications; central neuropathic pain in MS, allodynia and brachial plexus avulsion. In these trials the patients maintained all their existing analgesic medication in addition to taking the study medication.

Therefore symptom relief obtained from Sativex was over and above any effect achieved by the patients existing analgesia.

All completed trials are listed below, together with associated publications and/or GW press releases where available: Central neuropathic pain Phase III double-blind, randomised, parallel group, placebo-controlled study of Sativex in central neuropathic pain in multiple sclerosis. (Rog DJ et al. Neurology. 2005;65:812-99).

Phase II double-blind, randomized, three way crossover study comparing two different sub-lingual cannabis based medicines, including Sativex, with placebo, in patients with chronic pain due to brachial plexus injury. (Berman et al Pain. 2004;112:299-306).

Phase II randomized, double-blind, placebo-controlled, parallel group comparative study of the efficacy, safety and tolerability of sublingual cannabis based medicine (CBM) extracts and placebo in patients with intractable neuropathic pain associated with Spinal Cord Injury.

Peripheral Neuropathic Pain Phase II/III double-blind, randomised, placebo-controlled, parallel group study of Sativex in the treatment of peripheral neuropathic pain characterised by allodynia. (Nurmikko et al Pain. 2007: doi:10.1016/j.pain.2007.08.028M)

Phase II/III double blind, randomised, placebo controlled, parallel group study of Sativex in the treatment of subjects with pain due to diabetic neuropathy. For GW press release click here. Phase II/III double blind, randomised, placebo controlled, parallel group study of Sativex in the treatment of subjects with peripheral neuropathic pain, associated with allodynia.