Phase II clinical study was a double-blind, randomised, placebo-controlled, parallel-group trial designed to evaluate Sativex in patients with MS and overactive bladder (OAB) that was not responding adequately to currently available treatment for 8 weeks.
The trial showed improvements in a range of bladder symptoms, including nocturia, daytime frequency, frequency per 24 hours, and bladder symptom severity.
GW Pharma said that no effect was seen in the pre-specified primary endpoint of the study that is incontinence.
University of Nottingham Neurology professor Cris Constantinescu said that the data provide evidence for the positive effects of Sativex on bladder symptoms in patients with MS.
GW Pharma R&D director Stephen Wright said that the study demonstrates that in people with MS who have exhausted other treatments, Sativex improved some symptoms of bladder dysfunction.
GW Pharma said that Sativex received UK, Spain and Canadian approval as a treatment option forspasticity in MS and is marketed in the UK and Canada by Bayer Schering Pharma and will be marketed in the rest of Europe by Almirall.