Other Trials Review

Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is a chronic, progressive and disabling auto-immune disease and afflicts up to three per cent of the population in Western countries. It is a very painful condition which can cause severe disability and ultimately affects a person’s ability to carry out everyday tasks.

GW has completed the world’s first controlled trial of a cannabis-based medicine in treating pain due to rheumatoid arthritis (RA), with very encouraging results. Details of this trial are listed below, together with the associated publication and press release:

GW Sativex Rheumatoid Arthritis Pain Trial

Phase II double-blind, randomised, parallel group study to assess the efficacy, safety and tolerability of Sativex compared with placebo for the treatment of pain and stiffness caused by rheumatoid arthritis. (Blake et al. Rheumatology. 2006;45(1):50-2). For GW press release, click here.

Bladder Dysfunction

Ninety per cent of people with multiple sclerosis (MS) develop lower urinary tract symptoms after 10 years of disease activity.

GW has completed two trials of Sativex in treating bladder dysfunction in people with MS. Details of the trials are listed below:

The first study incorporated 135 patients with advanced MS who were experiencing bladder dysfunction ("Detrusor Overactivity") that was not responding adequately to currently available treatment. In the trial, Sativex achieved statistically significant improvements in a range of bladder symptoms, including nocturia (p=  0.01), daytime frequency (p=0.044), frequency per 24 hours (p=0.001), bladder symptom severity (p=0.001). A significant effect was also seen in the patient's global impression of change (p=0.005). There was also a strong trend in favour of Sativex in urgency (p=0.07). There was no significant effect on incontinence, the primary endpoint of the study. The adverse event data showed the medicine to be generally well tolerated.
 
Professor Clare Fowler, Professor of Uro-Neurology at the Institute of Neurology, UCL and Consultant in Uro-Neurology, National Hospital for Neurology & Neurosurgery, said, "This study demonstrates that in patients with MS who have exhausted other pharmacological treatments, Sativex improved some of their most troublesome symptoms of bladder dysfunction. The impact that Sativex had, particularly on frequency and nocturia in these patients was of significant benefit for them and was maintained in long-term use. The results suggest that Sativex will have a useful place in the management of these distressing problems."
 
The results offer promise that bladder dysfunction may provide a further new indication for Sativex in due course. Data from this study is expected to be published in a peer-review journal in the near future.

An earlier open-label pilot study has also been completed involving 21 people with MS  to assess the efficacy, safety and tolerability of Sativex for improvements in urinary symptoms; particularly urinary urgency and incontinence. (Brady et al. Multiple Sclerosis. 2004; 10:425-433).