GW Pharmaceuticals plc
announces positive preliminary results in a Phase II clinical trial in patients with pain caused by Rheumatoid Arthritis.
The multi centre double blind, randomised, parallel group study in 58 patients assessed the efficacy, safety and tolerability of Sativex®, a whole plant medicinal cannabis extract, compared with placebo for the treatment of pain caused by Rheumatoid Arthritis. Study medication was administered by means of a spray into the mouth as an evening dose only and measures were assessed the following day.
In the Phase II trial, statistically significant improvements were seen in a range of outcome measures including morning pain at rest (p<0.05), quality of sleep (p<0.05), disease activity score (p<0.01) and Short Form McGill Pain Questionnaire – pain at present (p<0.05). Analysis of morning pain on movement approached statistical significance in favour of Sativex.
Overall the number of adverse events experienced was similar between the treatment groups. The safety profile was consistent to that shown in previous Sativex studies with adverse events being generally mild or moderate in intensity.
Dr Philip Robson, Director of GW’s Cannabinoid Research Institute, said, “These results are particularly exciting because this is the first ever controlled clinical trial of a cannabis-based medicine in the treatment of arthritis. To date, GW’s research has concentrated on multiple sclerosis and neuropathic pain and it is therefore very encouraging to see these positive effects of Sativex on pain and other symptoms of rheumatoid arthritis. Future research in rheumatoid arthritis will examine the optimal cannabinoid ratios in this indication prior to selecting the product candidate to enter into a pivotal Phase III trials programme.
Dr Robson added, “This exploratory trial provides further strong support to our belief that cannabis-based medicines may offer therapeutic potential across a range of medical conditions.”