GW Pharmaceuticals announces positive preliminary results in a phase III clinical trial to assess the effects of Sativex on spasticity in 189 patients with Multiple Sclerosis (MS).
In the phase III trial, a statistically significant improvement in comparison with placebo was seen in spasticity as measured on a numerical rating scale (p<0.05), the primary endpoint in the study. Other secondary outcome measures, such as the Ashworth scale, were in favour of Sativex but did not reach statistical significance.
The trial was a multicentre double blind, randomised, placebo-controlled parallel group study. In addition to study medication, all patients remained on their existing medication during the course of the trial.
In this trial, the safety profile was consistent to that shown in previous Sativex studies with adverse events being generally mild or moderate in intensity.
Dr Geoffrey Guy, executive chairman, said, "This positive phase III trial further supports the efficacy of Sativex in spasticity, one of the most common symptoms of MS. The effects shown in this trial are over and above those achieved by patients on their existing treatments alone. In addition to improvements in spasticity, GW's previous phase III trials in people with MS have shown Sativex to reduce pain and sleep disturbance and improve quality of life."
Spasticity (spasms and stiffness) is one of the most common symptoms of MS occurring in as many as three-quarters of people with MS. Spasticity can affect many aspects of daily life, such as walking and sitting. It can range from mild to severe and change over time, often from day to day, hour to hour.
Sativex is a whole plant medicinal cannabis extract containing tetrahydrocannabinol (THC) and cannabidiol (CBD) as its principal cannabinoid components.