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.
Spasticity (spasms and stiffness) is one of the most common symptoms of MS occurring in as many as three-quarters of people with MS (source: MS Society). 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.
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.”
Sativex is currently the subject of regulatory applications in both the UK and Canada. In both countries, upon approval, Sativex will be exclusively marketed by Bayer HealthCare.
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Notes to Editors:
Sativex is a whole plant medicinal cannabis extract containing tetrahydrocannabinol (THC) and cannabidiol (CBD) as its principal cannabinoid components. The medicine is administered by means of a spray into the mouth.
Spasticity results from more than one group of muscles contracting incorrectly, causing spasms or stiffness. Spasms are uncontrollable muscle contractions and can be painful. They can be a particular problem at night causing disruption of sleep. Limbs may shoot away or bend upwards towards the body and severe spasms may make the back arch off the bed or chair.
Stiffness of the limbs is common and can make it difficult to perform normal activities, particularly delicate movements of the hand and fingers. If the leg muscles are affected it can make walking difficult.
Pain can be associated with spasticity, but spasticity is not always accompanied by pain. Current treatments are often only partially helpful
- GW MS Trials
GW has previously reported positive data from three Phase III trials which include patients with multiple sclerosis. A further Phase III trial is ongoing in patients with bladder dysfunction due to MS.